Jobs That Crossed My Desk Through March 3, 2013 Complimentary Service of Audreysnetwork.com

March 3, 2013

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org.

******************************************************** Interested Parties Please Contact: Katharine Rehahn Recruiter ICONMA 1.888.451.2519 Ext 111 kathairne@iconma.com www.iconma.com http://bull.hn/l/119ZM/5 I've got a great opportunity for a Jr/Mid Level Quality Engineer in Carlsbad CA. Please contact Katharine Rehahn at 888-451-2519 Ext 111 Know anyone for this job? Quality Engineer in Carlsbad, CA Quality Engineer Location: Carlsbad, CA Duration: 5-6 months Description/ Required Skills: - Tracks and initiates investigation of complaint trends. - Manages the Corrective and Preventative Action (CAPA) system. - Provides guidance for and assists with the process (re)validation activities. - Responsible for the implementation and management of the internal Quality Audit procedure and schedule. - Assures compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and

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finished goods. - Represents the site quality systems to customers in face-to-face meetings or through written and verbal correspondence. - May be required to perform other related duties as required and/or assigned. - Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. - Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. - Requires familiarity of c GMP.s and regulations applicable to the FDA. - Normally receives no instructions on routine work, general instructions on new assignments. - Requires strong, persuasive communication skills both verbally and in writing. - Work directly with Manufacturing teams on addressing product/process nonconformance’s, updating work instructions/SOPs, and manage CAPAs. - Ensure quality system protocols are being followed within the manufacturing process. - Update records as needed and prepare metrics for weekly review. Education: - Two plus year’s laboratory experience with a life sciences or medical diagnostics company. - Requires a Bachelors/Masters degree in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline. **************************************************** Posted by Jim Bishop, President and CEO - Bishop Executive Services LLC Dermatopathology Rep - Los Angeles Now hiring: Dermatopathology Rep - Los Angeles http://www.ziprecruiter.com/job/Dermatopathology-Rep-Los-Angeles/3b8ddba7/?source=social-linkedin-group-jobs ***************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5009771&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3Q5ErWgWTktBE1 For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com Regulatory Affairs Manager, Medical Device Pharmalink Consulting- San Francisco Bay Area Job Description • Offers strategic and operational regulatory support for identified medical devices projects involving in vitro devices, including PMA (Class III) devices. • In collaboration with management and regulatory project strategy teams, helps develop and review regulatory strategy for identified projects. • Interprets applicable regulations (21 CFR Part 820) and CDRH guidelines for project team use. Assists in keeping project team abreast of regulatory decisions, issues, potential problems, and new regulations. • Ensures timely submission of appropriate regulatory documents under direction of regulatory lead and in conjunction with Regulatory Operations. • Coordinates/solicits, reviews, and provides regulatory feedback on content of

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components for health authority submission from various functional areas. • Assists regulatory lead on assigned study teams to provide regulatory guidance on study activities. • Proactively raises major project issues to management for resolution and agreement. • Collaborates with other Regulatory Managers, and Regulatory Associates. • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses. Desired Skills & Experience Education & Experience Requirements • Bachelor’s degree is required in the scientific/health care field. • Experience with BLA submissions preferred, but not mandatory. • Possesses at least 7+ years of related experience within a medical device company, pharmaceutical company, CRO or similar organization and at least 4 years of direct experience with in vitro medical devices Key Skills and Competencies • Must be able to communicate comfortably and effectively with regulatory authorities. • Thorough knowledge of device design control and device regulatory submissions. • Proven ability to independently resolve problems. • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines. • Ability to work successfully within a cross-functional team. • Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. • Ability to work independently, take initiative, and complete tasks on deadlines. • Working knowledge of device filings including IDEs, PMAs and BLA filings. Company Description Pharmalink Consulting is the No 1 choice for sustainable outsourcing for all Regulatory Affairs requirements. We can resource any Regulatory Affairs project – regardless of size and timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world. Unlike some other consultancies, Pharmalink specialises in Regulatory Affairs only. The business has become so specialised in the last 10-15 years, it requires dedicated teams of Consultants to meet the increasingly complex demands of local health authorities and keep abreast of all the changes that are constantly happening on a global and local market level. For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com Additional Information Posted:March 1, 2013 Type:Contract Experience:Mid-Senior level Functions:Consulting Industries:Pharmaceuticals Job ID:5009771 ********************************************************

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Apply on company website for these Sterling Life Sciences positions To apply, please use this link: http://www.mybiotechcareer.com/JD/R-AND-D-Science-Engineering-General-Management-California-Biotechnology-Jobs-Careers-74416 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Clinical Program Manager Sterling Life Sciences - California (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/R-AND-D-Science-Engineering-General-Management-California-Biotechnology-Jobs-Careers-74416 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Oversee all trial operational aspects, including budgets, timelines, resources, vendor selection and clinical team staff during study start-up, interium monitoring and closeout activities 2) Manage multiple clinical trials 3) Manage one Anemia, Pre- Dialysis and Phase II global trial 4) Manage clinical study teams, CROs and vendors to ensure that the studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted.

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Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159174416 Job ID:5001135 ****************************************************** Apply on company website Medical Science Liaison (Hepatitis C) Boehringer Ingelheim - San Francisco (San Francisco Bay Area) Job Description The MSL I will function as a field based extension of Medicine serving as a liaison between Scientific Experts (SCEs) and BI Medicine in order to deliver scientific insights to the organization which address the scientific needs of the Hepatitis C Virus (HCV), Medicine colleagues, and influence strategic decision making and planning for compounds in development or products on the market. The MSL I will also function as an extension of the Medical and Technical Information (MTI) department in order to respond to HCP inquiries for scientific information and data. The MSL I will support the Clinical Development Medical Affairs (CDMA) HCV department including Scientific Affairs activities. At the direction of Clinical Operations, the MSL I may provide clinical trial support at various stages of a development program. The MSL I may provide scientific support, at the request of Commercial, for internal and external activities where there is a defined scientific role for Field Base Medicine (FBM). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities:

The MSL I proactively interacts with SCEs within their assigned geography to support the Scientific Objectives (SOs) of the HCV Team. Through scientific exchange (SE), the MSL I will act as a scientific resource to SCEs and HCPs to answer specific questions on Hepatitis topics and BI compounds. The MSL I is responsible for establishing and maintaining scientific relationships with SCEs and having a strong understanding of the scientific landscape within their assigned territory. The MSL I will conduct SEs with SCEs, HCPs, as well as active and potential study investigators (BI-sponsored studies or IIS). The MSL I is responsible for providing field generated scientific insights regularly to FBM management.

The MSL I will provide scientific support for CDMA (BIPI & Corporate) and support Scientific Affairs activities such as Medical Grant Program Evaluations and Medical Publication Author Identification. The MSL I will also attend assigned scientific conferences, staff non-promotional Medical Information booths, as well as contribute to the development of the conference report.

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The MSL I will adhere to all relevant BI policies and procedures and compliance expectations for FBM activities. The MSL I will incorporate ethical decision-making into all business practices.

The MSL I will maintain clinical, scientific, and technical expertise in specific TA through continuous learning and knowledge of the Hepatitis related scientific literature.

Desired Skills & Experience Doctorate degree (PharmD, M.D., DO, Ph.D.) with 1 or more years of relevant clinical or

therapeutic area experience in Hepatitis. Masters level degree in health sciences with 3 or more years of relevant clinical or

therapeutic area experience in Hepatitis. Previous MSL experience desired. The position is field-based with upwards of 75% required travel (car, train and plane) to

manage assigned geography. Easy access to large hub airport desired. Ability to use field-based electronic or other communication tools for all aspects of job is

critical, as well as the ability to maintain excellent relationships with scientific experts and health care providers.

Company Description The objectives and beliefs of Boehringer Ingelheim can be summed up in a single phrase: Value through Innovation. This vision has helped us build on our strengths and make the most of our distinctive character for over 125 years. Value through Innovation is what drives us to continuously search for new and innovative ways to bring more health to the lives that we touch - whether that be lives of patients and their families, our employees or our community. Boehringer Ingelheim is committed to furthering science that benefits the health of patients and their families. Over the years, we have brought a range of successful products from drug discovery to market. Learn more about successful products from our own Research & Development as well as examples of promising compounds in our pipeline by visiting: http://www.boehringer-ingelheim.com/research_development/drug_discovery/pipeline.html Boehringer Ingelheim is a globally operating group of companies with 138 affiliated companies worldwide and nearly 43,000 employees worldwide. Our business areas Our Human Pharmaceuticals business area covers the segments: • Prescription Medicines • Consumer Health Care • Biopharmaceuticals • Operations (Pharma Production and Chemical Production) In Animal Health, our core business segments serve food-producing and companion animals. Additional Information Posted:March 2, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other, Science Industries:Pharmaceuticals Employer Job ID:130683 Job ID:5011526 ______________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-California-Biotechnology-Jobs-Careers-74698 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Clinical Research Associate / CRA Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to

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the Lead Recruiter. 1) Monitor one or more clinical trials 2) Participate in the design and writing of protocols, case report forms and informed consent forms for all clinical trials 3) Initiate and coordinate study start-up activities, including investigator identification and selection, contract and budget preparation, presentation at investigator meeting and vendor/investigator training 4) Take responsible for study management, including CRO, central lab and vendor management 5) Collect documents and generate supplemental material, including monitoring plans, data management plans and training materials 6) Ensure site evaluations, investigator meetings, study initiation, monitoring, closeout visits, review of case report forms, adverse event recording and reporting 7) Manage and ensure that the studies are conducted and adhere to FDA/ICH guidance on Good Clinical Practices (GCP) 8) Monitor investigator performance and ensure protocol compliance and patient safety 9) Ensure that Case Report Forms (CRFs) are reviewed, pulled in a timely manner and submitted to Data Management 10) Assist in writing and compilation of the clinical report for submission 11) Coordinate clinical supply requirements, shipping and key documentation with global R&D locations TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level

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Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159174698 Job ID:5001134 ______________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-84415 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Regulatory Affairs Associate / RA Associate Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Assist in reviewing and maintaining documentation associated with manufacturing and vendor qualifications 2) Coordinate and support the development of the finished product stability program 3) Assist in maintaining the R&D database 4) Represent R&D by offering technical assistance to multiple groups within the company, including quality control 5) Oversee regulations, research and current events in regards to product labels, product claims and nutritional values, and material issues 6) Maintain up-to-date knowledge of laws, regulations and policies enforced by the federal, and the state governments 7) Author submissions and other regulatory documents to obtain approval to bring new or modified products to market TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also

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welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159184415 Job ID:5001119 _____________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Quality-R-AND-D-Science-Laboratory-California-Biotechnology-Jobs-Careers-87456 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Sales Account Manager, Lab equipment ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Grow new accounts, identify new opportunities and build relationships to gain new business revenue for the company 2) Implement effective sales plans to position the organization competitively and meet / exceed territory objectives 3) Identify the needs of new prospects and develop appropriate responses 4) Perform field calls for the account and assigned territory 5) Participate and attend sales meetings and professional association meetings outside of regular business hours, as required 6) Build and maintain key alliances with distributors and field sales team 7) Communicate with all levels of management within both the distributor and field sales organization TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on

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Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159187456 Job ID:5001094 ********************************************************* Meredith McClanahan Recruitment Services Specialist at BioPhase Solutions LocationGreater San Diego AreaIndustryStaffing and Recruiting http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=2830 Scientist Engineer BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Scientist Engineer to work for a leading Bay Area biotechnology company. BioPhase Solutions is recruiting for a Scientist Engineer in Signal Processing and Algorithm Development for Next Generation Sequencing. This is a direct-hire full time position with our exciting start-up client located on the San Francisco Bay Area Peninsula. In this role, you will be a key player in the development of DNA Sequencing technology for healthcare and diagnostics. __________________________________________ Regulatory Affairs (Orange County, CA) BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for Regulatory Affairs professionals to work for a leading Orange County Medical Device company.

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http://www.biophaseinc.com/viewjob.php?jc=j_cli&rec=252 _____________________________________________________ http://www.biophaseinc.com/viewjob.php?jc=j_cli&rec=251 Sr. Regulatory Affairs Associate (fluent in Japanese) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Sr. Regulatory Affairs Associate to work for a leading Bay Area biotechnology company. BioPhase Solutions is recruiting for a Senior Regulatory Affairs Specialist with language skills in Japanese for our major medical diagnostic client located in Santa Clara, CA. This is a full time direct-hire career opportunity. ****************************************************** Posted by Whitney Hood Recruiting Consultant at Real Staffing San Francisco Sr. R&D Engineer Real Staffing Group- Irvine, CA (Orange County, California Area) Job Description R&D Project Engineer. This position is responsible for the research, design, and development of endovascular delivery systems and implantable medical devices for the treatment of peripheral and cerebrovasculature diseases Major Responsibilities: • Establishing product customer requirements, concept prototyping, conducting and overseeing product testing, design and development (including verification and validation), material selection, risk/failure mode assessment, performance and safety. • Develop and validation of test methodology • Interfacing with Physicians • Perform pre-clinical in-vitro and in-vivo testing • Assisting with pilot-production and post production GMP compliance • May directly supervise one or more technicians • Complete documentation of all project data (responsibility to assure accuracy and completeness) • Comply with applicable FDA / ISO13485 Job Requirements: Education/Experience: • Bachelors degree in Mechanical Engineering or similar field with 5+ years direct experience or Masters with at least 3+ years experience is required. Minimum of three years of experience in catheter design. Skills and Experience: • Extensive experience in the mechanical design and testing of medical products - specifically disposable catheter systems.

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• Catheter and medical implantable device experience including writing protocols and reports to support verification and validation activities for product commercialization. . • Minimum 5 years in medical device development. • Computer skills, to include spreadsheets, word processing, project scheduling, AutoCad, Solidworks • Working knowledge of FDA/GMP and ISO regulations (Design Controls). • Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports. • Strong, team-oriented professional with good interpersonal skills and project management experience. • Timeline and budget development and management • Independent self-starter requiring minimal daily supervision Salary: $90K to $125K + bonus, equity, benefits etc depending on experience. Location: Santa Ana, CA Company Description Real Staffing is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services and has one of the largest networks of specialist recruiters globally. Our premise is a simple one: by recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time. At Real Staffing we offer retained search as well as contingency recruitment within both the contract and permanent markets. Our consultants are market specialists and it is this in-depth market knowledge that allows our consultants to develop tailored recruitment solutions for this demanding recruitment market. We take the time to understand our candidates' current and future ambitions and actively seek out roles that will help take our candidates to the next level in their career. The strength of our client relationships and global network means we can access the best new roles within the sector. Whether you are looking to strengthen your team or looking for your next career move contact us today. www.realstaffing.com Additional Information Posted:February 27, 2013 Type:Full-time Experience:Not Applicable Functions:Project Management, Manufacturing, Business Development Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:$90K to $125K + bonus and equity package Job ID:4986609 ************************************************** Posted by Stan Cross, Clinical, Scientific and IT Recruiter http://bull.hn/l/1188J/3 HR Associate | San Carlos, CA Hiring a Human Resources Associate in San Carlos, CA

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looking for a HR Associate for a short term contract position in San Carlos, CA. The Human Resources Associate is responsible for providing confidential administrative, operational and project support to the Human Resources Team; responds to managers and associates requests for HR materials, job information, and route to appropriate resource or other HR colleague as required. •Serves as initial contact person in the Human Resources Department, providing direction on site policies, practices and procedures. •Participates and assists with department projects and activities as requested; works with HR staff on implementation of new programs/procedures or to solicit assistance in the resolution of a HR related issue; researches and compiles information for special projects as needed; and look for opportunities to enhance the effective of site HR delivery systems. •Coordinates and schedules meetings, interviews, appointments, etc. •Prepares and ensures appropriate materials are available. Creates overheads for presentations using presentation graphics software as requested. Writes, edits and proofs correspondence, reports, memos, etc. •Maintains files and records for Human Resources. Maintains, data enters and ensures the accuracy of information into assigned department databases and spreadsheets. Requirements •2-5 years in a Human Resources experience. •Complete understanding and use of human resources planning concepts/principles. •Full knowledge of pharmaceutical industry practices. •Ability to handle multiple projects and activities and work under pressure. •Demonstrated ability to work with limited daily direction; and able to exercise considerable initiative to provide a variety of advanced analytical and general HR administrative tasks. •Proficiency with word processing, spreadsheet and presentation graphics software. Microsoft Word, Excel, PowerPoint, and Outlook preferred. •PeopleSoft, applicant tracking system (BrassRing) or other HRIS systems experience highly desirable. ____________________________________________________ http://bull.hn/l/11HLV/6 Sr. HR Rep | Brea, CA Are you a good fit for this job? Sr. Human Resource Representative in Brea, CA The Human Resources Manager will design, implement, and support strategies and programs to enhance the effectiveness of managers and the productivity and satisfaction of employees at the Brea site. The incumbent will optimize relationships between employee and employer; link human resources strategies to business objectives: ensure compliance with all labor laws; counsel and advise management on a variety of topics related to human resources and design and implement training, performance management, and organizational design programs. Drives and manages Workforce Planning and Headcount management Provides consultation and training on Engagement & Retention of associates Drives and manages Performance Mgmt processes including coaching leaders on tough conversations, co-creating performance improvement plans and ensuring leaders are following through with the annual process. Consults with clients on internal movement decisions; transfers, promotions, job enhancements and ensures decisions are in line with company policy and leveling guides. Conduct Employee Relations investigations and consult with managers and ER counsel on outcomes and next steps. May co-facilitate training and development programs. Delivers change management consultation to clients

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Reports monthly metrics to HR leadership and drives to ensure that countermeasures are in place when not hitting targets. ] Consults with leaders on talent management and organizational design challenges. Job Requirements Include • BA with an average of 9+ years of HR experience with 2+ years as a generalist or MA with an average of 7+ years of experience as a junior business partner or field generalist • Solid and sophisticated skills in: consulting, contracting, mediating, negotiating, coaching • Experience in compensation, recruiting, employee relations, organizational development is preferred (ideal mix 2 or more areas) • Working knowledge of employment law including Title VII, ADA, ADEA, FMLA, FLSA, OSHA and Workers Compensation • Thorough and deep knowledge of the employee life cycle • Has had experience leading or contributing to small to medium scale re-orgs, org alignment, workforce planning efforts • Has had previous experience managing complex and cross-functional initiatives, processes, or projects • Exposure to and comfort with higher management ************************************************* Posted by Darshana Nadkarni, Ph.D. For the opportunity below, please send resume to wd_darshana at hotmail dot com. Prototype Hardware/Firmware Design Engineer - SF, CA Other opportunities are posted in JOBS category at the link below. Prototype Hardware/Firmware Design Engineer - SF, CA There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus. Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology. Darshana Varia Nadkarni's Blogdarshanavnadkarni.wordpress.com Jobs in Biotech & Medical Device... ********************************************** Posted by Jeff Randles, Account Manager - Sr. Recruiter at Precept Life Sciences Contract Regional CRA in Los Angeles, CA Now hiring: Contract Regional CRA in Los Angeles, CA http://www.ziprecruiter.com/job/Contract-Regional-CRA-in-Los-Angeles-CA/bd74e788/?source=social-linkedin-group-jobs

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************************************************ Posted by Shantanu Lajmi, Entrepreneur ★ Founder ★ rawDATAjobs.com ★ practiceHRM.com ★ SEEKING 'DATA ANALYTICS' professionals in USA with 2-4 yrs work exp, RECRUITMENT DRIVE @ Los Angeles, CA-Saturday, 9th March 2013. Interviews & Spot offers! (H1B/OPT/EAD/GC/USC) http://lnkd.in/X2TpqT Data Analytics professionals across domains (some experience in PHARMA domain preferred/not mandatory) for SF Bay Area, California, USA. Please email CVs to: Careers@rawDATAjobs.com Position: ASSOCIATE - Analytics (Full-time/Permanent)rawdatajobs.com Job Location: San Francisco Bay Area, CA (Interviews on Saturday- 9th March, 2013 , Spot offers for selected Candidates!) Our Client is an 'award-winning' pure-play Analytics and decision sciences organization, based out of USA... ****************************************** Posted by Isabel Brito, Atlantic Management Resources Send resumes to ibrito@amrjobs.com We're looking for sales in Central LA. We're looking for strong pain sales reps with excellent hospital experience (a must) in Central LA. This is a great opportunity to work for a small, growing pharma company. ************************************************ Started by Venkat Giri, Clinical & Scientific Recruiter at Makro Scientific Apply Online http://www.wisestep.com/ROFQSOOQ/IRDGFKEFJE or Refer Friends who will love to take it. Hiring for Associate Scientist I at Foster City, CA and is looking for suitable candidates. I am using wisestep.com to share my jobs on Multiple Linkedin Groups with a single click. Job Description: Makro Scientific: Life to Life for Better Life. Makro Scientific: Staffing Specialist in Clinical and Scientific. Job ID : LVG-31167 Job Title : Associate Scientist I Duration : 10/31/2013 Location : Foster City, CA Duties: Conduct pre-designed scientific or engineering experiments using laboratory equipment and calculations. Verify and validate product design and performance during the development cycle, from feasibility through product release. Products include benchtop instruments, sample preparation, synthetic biology, protein expression, protein analysis, and enzymes. Plan the use of equipment, materials and own time. Assist in lab procurement, calibration or maintenance of equipment. Make detailed observations and basic data analysis. Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. Suggest options /ideas for additional experiments. Troubleshoot experiments with assistance from supervisor. Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment. With supervisors guidance, become familiar with literature directly associated with assigned project and transmit information gathered to other members of the scientific team. Maintain complete and thorough lab notebook and training file in accordance with division standard. Comply with all company safety regulations and procedures. Position exercises judgment within defined procedures and practices to determine appropriate action. Normally receives general instruction on routine work, detailed instruction on new assignments. Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. Works on problems where analysis of

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situation or data requires a review of identifiable factors. Accuracy is required in performing all functions of this position, mistakes in work could cause substantial interpretive errors. May be required to perform other related duties as required and/or assigned. Main duties would include, but may not be limited to: Running tests and experiments in the laboratory. Preparing PCR reaction plates and running on AB qPCR systems. Contributing to writing and executing test plans and reports. Executing statistical data analysis. Major responsibilities are understanding and executing procedures, accurately recording data, and assisting in data analysis. Skills: Experience working in a lab environment and familiarity with basic laboratory practices a must. Good communication skills and experience developing testing, measurement and characterization methods are desired. Familiarity with proper documentation practices and technical writing experience, including creating test protocols and SOPs is desired Experien ********************************************************** Senior Consultant – Rachel Riley, r.riley@realstaffing.com Clinical QA Consultant Real Staffing Group- San Francisco Bay Area Job Description Clinical QA Consultant A pharmaceutical company in the Palo Alto, CA area is looking for a Clinical QA Consultant to join their team. This is an excellent opportunity to join a start-up with an exciting pipeline. Clinical QA Specialist Overview: Provides critical direction, documentation, deliverables, assistance and support for all quality control compliance functions related to Good Clinical Practice (GCP) for clinical development activities. Ensure high level GCP compliance, documentation and adherence to company’s and external partners SOPs. The position requires a strong working knowledge of FDA regulations and guidance documents, International Conference on Harmonization guidelines and cGCP guidelines. Through proactive and comprehensive compliance initiatives directed by the Clinical Compliance Specialist, the company’s clinical development activities will be conducted at a very high level consistent with GCPs with robust documentation to provide confidence and assurance in all clinical data and results generated. The Clinical QA Specialist will have the following responsibilities and roles:

Clinical SOPs, processes –development, revision, training and implementation of required SOPs

Oversight and accountability for compliance within the Clinical Department with internal SOPs, process, and regulatory requirements by:

Identifying process gaps Performing internal process assessments of clinical operations and or documentation Effectively documenting process improvements to demonstrate due diligence with

proactive compliance Identifying the critical components to achieving increased clinical compliance through a

risk-based approach Identify and development of specific tools, critical documents needed to track

compliance, and processes to enable proactive and systematic detection, analysis, remediation and prevention of compliance quality issues/risks

Identifying useful indicators for assessing compliance for ongoing performance of clinical vendors

Evaluating performance indicators tracked to ensure GCP compliance is maintained and to alert management of potential non-compliances

Effective strategies for tracking and recording changes to study documentation Participate in end of study documentation compliance reviews including data set review,

Tables, Listings and Findings, CSR, Trial Master File reconciliation

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Serve as Clinical interface with Topica’s Quality Assurance Group for all GCP internal and external audits and CAPA.

Some travel may be required to key clinical vendor sites and clinical research sites. Desired Skills & Experience Clinical QA Specialist Requirements:

Minimum BS or equivalent and minimum 10 years clinical research experience in a pharmaceutical/biotech company working within clinical compliance, process improvement, and/or risk management

Proven ability to work independently, efficiently and effectively Effective communication and time management skills critical to achievement of QC

goals; Good working knowledge of clinical development software (IWRS, Rave, MS Office etc.); Familiarity with an outsourced clinical trial model; Ability to represent Topica effectively with CRO and key external vendors, and; Excellent documentation skills and systems design.

If you are interested in this position, please respond to this job positing ASAP. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information

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Posted:February 28, 2013 Type:Contract Experience:Director Functions:Quality Assurance Industries:Pharmaceuticals Job ID:4988803 ******************************************************** Posted by Craig Charyak, Talent Manager Please send resume to ccharyak@r-dpartners.com and/or call (415) 374-8872 R&D Partners is seeking a Cleaning/Equipment Validation Engineer for a 12 - 18 month project in San Diego, California . Cleaning/Equipment Validation Engineer in San Diego, CA R&D Partners is seeking a Cleaning/Equipment Validation Engineer for a 12 - 18 month project in San Diego, California . Please send resume to ccharyak@r-dpartners.com and/or call (415) 374-8872 See below job description Responsible for generating, executing, and finalizing equipment, IQ,OQ,SIP and cleaning validation. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site. Working closely with Engineering, MSAT, Quality Assurance and Manufacturing. requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams. Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s). Generation of Tracability Matrix Participate in cross-functional team meetings and where required Sound knowledge and understanding of GMP guidelines, USP, and CFRs applicable to the pharmaceutical/biotechnology industry. Skills: -Ability to manage technical projects through to completion to achieve results. -Logically and methodically works through complex problems to identify root causes and provide rational solutions. -Proven effective verbal and written communication skills. -Delivers results -Understands the validation process and recognizes supplier limitations and customer expectations. -Accountable for projects, and communication. -Seeks guidance and support when required. Education: Bachelor's Degree Required http://bull.hn/l/11ESW/1 *******************************************************

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Posted by Kendra Bullock, Researcher - Northeast Region at inVentiv Health Email Kendra.bullock@inventivhealth.com. Looking for Part-Time Pharmaceutical Sales? Do you live near Riverside, CA, Las Vegas, NV, San Francisco, CA or Dallas, TX? ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=301FF649-3812-4CDC-A0EE-223AB40A20F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 REGULATORY AFFAIRS SPECIALIST Masimo Corporation Job Description Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion. To learn more about us, please visit: www.masimo.com Job Summary: In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations. From coordinating with international regulatory team members on product changes to maintaining up-to-date information on domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent’s medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people’s lives. Duties & Responsibilities:

Support the regulatory team managing international and domestic filings/registrations; Coordinate with international regulatory team members on product changes and

regulatory notification / approval requirements; Assist in maintaining product list on Certificate of Foreign Government; Maintain up-to-date knowledge on international and domestic regulatory requirements; Generate and maintain product compliance checklists; Provide regulatory support to the OEM Deployment group; Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports; Submit document change orders (DRO/agile) for approvals; As requested by supervisor, represent RA department in project meetings and provide

regulatory guidance;

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Update RA responsible quality system procedures as required (SQP/SOP’s); Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience: Minimum Qualifications: Computer Proficiency with MS Office (Word/Excel/Access/Outlook);

Excellent verbal and written communication skills; Excellent prioritizing, organizational, and interpersonal skills; Excellent documentation skills including record maintenance/tracking and understand

document traceability; A detail-oriented individual with a “can do” attitude; Ability to work in a team environment as well as individually with minimal supervision; Ability to work in a fast-paced , Project Team environment, with multiple

tasks/projects; Preferred Qualifications:

Some previous work experience in a medical device Class II/ III environment; Experience in patient monitor systems, hospital-based products, software or electronic

device products; Knowledge of regulatory submission requirements for FDA Class II medical devices, and

equivalent classification requirements for international submission; Experience with FDA/GMP requirements for medical device; Experience in Quality Systems, per ISO 13485;

Experience with the UL/ETL certification process;

Experience interacting with regulatory bodies, such as the Notified Body; Education: High School or GED is required. Some college level coursework is preferred. BA/BS Degree is a definite plus. Physical requirements/Work Environment This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

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Masimo is proud to be an EOE, M/F/D/V, and we value and are committed to Diversity at every level. ******************************************************************************************************* Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Contact cheryl@biophaseinc.com if interested! Management Leader in Sequencing Technology BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Management Leader in Sequencing Technology to work for a leading Bay Area biotechnology company. Management Leader in Sequencing Technology BioPhase Solutions is recruiting for a direct-hire full time employee for our exciting start-up client located on the San Francisco Bay Area Peninsula. In this role, you will be a key player in the development of DNA Sequencing technology for healthcare and diagnostics. This is a leadership role at the Director to Sr. Vice President level. Responsibilities will include: Lead a team in biology, chemistry, and sequencing to include chemistry, sample preparation, and applications. Design and analyze experiments. Collaborate closely with scientists and engineers working on development of signal processing, bioinformatics, sensor technology and instrumentation. Establish and manage relationships with early-access collaborators; and help to identify optimal early applications for sequencing technology. Requirements: PhD in chemistry, biology, or equivalent, with 10+ years of biotechnology industry experience. Experience with Next Generation Sequencing technologies, sample preparation, and applications required. Experience with assay development and/or life science instrumentation product development. Ability to have productive collaborations within a multidisciplinary environment. Excellent communications skills – ability to speak clearly about the technology both internally and externally. Proven ability to drive new technology forward at a rapid pace. Strong analytical skills. Familiarity with bioinformatics and data analysis methodologies. Experience building and leading strong, talented teams of scientists. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. ________________________________________________________ Bioconjugation Scientist BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Bioconjugation Scientist to work for a leading Bay Area biotechnology company. Bioconjugation Scientist

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This is a temporary position located in Fremont, CA, supporting our growing medical diagnostics client. In this role, you will be working with a team of scientists, engineers and manufacturing personnel in the development and scale-up of cell-based diagnostic devices; and assist the R&D team in the development and optimization of bead based reagents, manufacturing and QC. http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=2822 **************************************************** Posted by Jennifer Harvey, HR Business Partner at Veracyte Reimbursement Specialist - Temp (Possible Temp to Perm) Now hiring: Reimbursement Specialist - Temp (Possible Temp to Perm) http://www.ziprecruiter.com/job/Reimbursement-Specialist-Temp-Possible-Temp-to-Perm/7938e3e6/?source=social-linkedin-group-jobs _________________________________________________ Clinical Trials Manager Now hiring: Clinical Trials Manager http://www.ziprecruiter.com/job/Clinical-Trials-Manager/e25f445c/?source=social-linkedin-group-jobs ******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4963354&trk=eml-anet_dig-b_premjb-ttl-cn&ut=0AqyRhzJ_UmlE1 Associate Director/Director of Regulatory Affairs (Clinical Development) Real Staffing Group- San Francisco Bay Area Job Description Associate Director/Director of Regulatory Affairs (Clinical Development) A small to medium sized pharmaceutical company in South San Francisco is looking for an Associate Director or Director of Clinical Regulatory to join their team. This is an excellent opportunity to join growing a company with a product out in Canada and the EU and looking to get their drug approved in the US. Summary: Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate. Duties and Responsibilities:

Responsible for contributing to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).

Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.

Represent regulatory on relevant project teams. Mentor other Regulatory staff members. Identify/assess and timely communicate regulatory risks for assigned projects or

programs. Prepare and deliver effective presentations for external and internal audiences, as

required. Interact with regulatory agencies relevant to assigned projects or programs, as

appropriate. Contribute to life-cycle management of products.

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Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.

Desired Skills & Experience Qualifications:

Minimum 8+ years in Regulatory Affairs Experience in providing regulatory support for all phases of clinical development. Experience with multipleINDand CTA filings and maintenance Experience and knowledge in the preparation of major regulatory submissions (NDA,

NDS, or MAA) and supportive amendments or supplements. Demonstrated excellent communication skills. Demonstrated strong organizational skills, including the ability to prioritize personal and

direct reports workload. Strong interpersonal skills and the ability to deal effectively with a variety of personnel

including medical, scientific, quality and clinical supply/manufacturing staff. Experience in interfacing with relevant regulatory authorities Experience in interpretation of regulations, guidelines, policy statements, etc. Experience working on products in development specifically relating to clinical and pre-

clinical regulatory aspects of the project. Good knowledge of GCPs and GLPs. Demonstrated effective cross-cultural awareness and capabilities.

Education: BA/BS/University degree required, Life/Health Sciences preferred. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated

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consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:February 25, 2013 Type:Contract Experience:Director Functions:Quality Assurance Industries:Pharmaceuticals Job ID:4963354 ********************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-87928 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Director of Sales ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Responsible for representing all company products, maintaining base business, acquiring new business and meeting or exceeding annual sales goals. 2) Maintain call frequencies at hospitals, laboratories and physician accounts. 3) Represent the company to the customer in a manner that demonstrates the highest degree of integrity. 4) Attain a practical understanding of company products, methodologies and competition. 5) Utilization of good selling skills that allows for the identification of need and presentations based upon identified need. 6) Completion of tenders and presentations within assigned territory. 7) Have good understanding and working ability in Microsoft programs. 8) Strong relationship building skills with customers, vendors and co-workers. 9) Prompt reporting of competitive information and updates as to existing market conditions. 10) Update and adjustment of current customer base pricing. 11) Aid in the training and development of new sales employees. TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on

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Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Director Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151187928 Job ID:493507 __________________________________________ VP of Regulatory Strategy and Product Development Sterling Life Sciences - California (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/R-AND-D-Science-Engineering-Product-Management-California-Biotechnology-Jobs-Careers-87978 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials 2) Develop strategies for regulatory approval and introduction of new products to market 3) Manage the process from development of regulatory strategies through to approval 4) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval 5) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards

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6) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements 7) Establish appropriate risk analysis activities which include the use of risk analysis tools TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Executive Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151187978 Job ID:4935064 ___________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-88545

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or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Vice President of Business Development ( Sales ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Initiate marketing strategies and co-ordinate actions to influence the market 2) Clarify goals and reach agreement maintaining the interests of all parties 3) Proactively develop and improve products and services 4) Build and maintain excellent relationships with colleagues and clients 5) Set sales targets and define strategy to achieve these targets and to follow the set strategy punctually 6) Manage the proposal development process and maintain the time-lines for the proposal teams 7) Co-ordinate with sponsors concerning size, standards, conditions and timing of research 8) Develop draft proposals based on team meetings and discussions 9) Maintain the business development databases 10) Support marketing activities, including trade / scientific shows, mailings, etc. TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials.

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Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Executive Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151188545 Job ID:4935057 *****************************************************

Jobs That Crossed My Desk Through Feb. 24, 2013 *************************************************** Check out website at Cepheid Posted by Ron Bucher, Customer Support and Services Executive Senior Service Repair Technician in Sunnyvale Will repair IVD instruments in our HQ repair lab (little or no travel). This position might be a good first job opportunity for a recent college graduate who has a technical degree (biology or engineering) and is adept at repairing equipment. Company has great technology and a very bright future. Great place for career growth. ______________________________________________________________ Senior Service Coordinator (dispatcher) in Sunnyvale QAD experience is a big plus. World class customer support experience required. ________________________________________________________ Service Logistics Manager in Sunnyvale Information systems knowledge must be very strong. ********************************************************* Posted by Taylor Langston, Social Media & Sales Support Specialist at PharmacyWeek, Inc. Like · Flag

Quality Control Coord, CAPS, San Diego, CA (BS/BA Biology, Microbiology, Chemistry, Pharmacy)

http://www.pharmacyweek.com/career/26306/Quality-Control-Coordinator-San-Diego-Ca-California-Ca-San-Diego

*********************************************************** Posted by Giovanni Lauricella, Medical Device Search Consultant at The Mullings Group I would like to share more information with you. Please send me a copy of your resume to Giovanni@MullingsGroup.com VP of Medical & Clinical Affairs – Bay Area – Hematology Biologics/Device Ground breaking biologic company based in the Bay has discovered a proactive procedure for blood transfusion. We are looking for a VP of Medical & Clinical Affairs. Must have: • MD degree • Phase III clinical trial experience

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• Willing to travel 30% internationally • Hematology or oncology experience *************************************************************** Posted by Shelly Glasgow, Technical Recruiter at ProPharma Group Quality Engineer (APR) Consultant - Bay area Now hiring: Multiple Quality Engineer (APR) Consultants - Bay area. For immediate consideration, apply online at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Quality-Engineer-APR-Consultant-Bay-area/3a2c7d30/?source=social-linkedin-group-jobs ********************************************** If you are qualifiied and interested in this role please contact me privately at dave@alpinesearch.net. Due to the volume of replies only qualified respondents will be contacted. Dave Murphy The Alpine Group.

Molecular Diagnostics Marketing Director - Bay area

A high growth Molecular Diagnostics client of mine is expanding and hiring a Director for their clinical marketing team. The Business Unit grew 70% in 2012 and exceeded forecast by 10%. The Director will lead a franchise of Molecular Genetics products used in clinical applications, and the role will include both upstream and downstream marketing duties. The marketing team is small with few layers so this will be a very broadly defined assignment where you will "wear a lot of hats." Qualifications: 8+ years of upstream and downstream marketing experience in the Life Science industry 5+ years of marketing experience in Molecular Diagnostics or Genetic Testing with products / services for clinical applications Expertise in Genetics / Molecular Biology tools and techniques Bachelor's degree in the Life Sciences is required; advanced degree is preferred

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Apply on company website Commercial Leader, Americas Region Onyx Pharmaceuticals- REMOTE (San Francisco Bay Area) Job Description Responsible for the management, oversight, and direction of the operations in the Americas region, including responsibility to interface and manage the distributors partnerships, operational performance, drive sales and market share growth, profitability, and contractual compliance. Essential/Primary Duties, Functions and Responsibilities:

Supports corporate development and regional leadership teams in the analyses and evaluation process of partners and distributors in the Americas region

Assists in the development and oversees the execution of the regional commercial strategy and annual plans

Partners with distributors to create market overviews, market development, product launch, marketing plans and sales forecasts

Evaluates distributor performance and tracks against agreed metrics and distributor agreement

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Leads Onyx cross regional execution team for America’s to meet regional goals and corporate objectives.

Evaluates and projects scenarios for optimizing Onyx portfolio value in the region. Develops business plans and trigger analysis for step wise affiliates (e.g. Brazil)

Closely manages and tracks budget for the region Tracks planning and implementation of product launch and other key marketing

activities Keeps abreast of changing market trends and opportunities to enhance revenue stream

and market share growth in each country Influences and motivates local distributor/partners teams to exceed sales and

profitability expectations Supports transfer of product knowledge to distributors by helping assess needs, deliver

training programs and overview the creation of marketing materials In partnership with local distributors provide appropriate scientific and marketing

support for key events including but not limited to advisory boards, launch symposium, new indication reviews, competitive positioning, managing pricing within regional & global pricing agreements etc.

Monitors compliance of distributors with relevant laws, regulations, company policies and terms of contract

Collaborates with cross-functional teams, including global product strategy, US sales, finance, clinical development, medical affairs, training, regulatory and others

Develops and delivers presentations as needed to commercial management and other internal groups

Desired Skills & Experience Requirements Work Experience:

10+ years of work experience in product marketing, field sales, strategic planning, finance or management consulting in the pharmaceutical/biotech industry, with at least 5 years in Latin American markets

Experience in market assessment, commercial planning, forecasting and product launch in foreign markets required

3+ years of oncology experience preferred Management of Staff: No direct reports upon hire Functional/Technical Knowledge & Skills:

Strategic thinking with the ability to formulate, develop and execute comprehensive plans

Excellent organizational, analytical and problem solving skills Successfully handle multiple tasks concurrently Ability to prioritize, plan, work independently and take responsibility for commercial and

operational issues Demonstrated ability to communicate effectively (both orally and written) and work well

in cross-functional and multi-cultural teams Proven ability to influence without line authority Ability to develop and maintain strong, professional relationships Proficiency in personal computer applications, including the creation of financial models,

forecasts, and P&Ls Customer & Industry Knowledge:

Comprehensive knowledge of the pharmaceutical industry Deep understanding of the competitive environment and relevant laws and regulations

in Latin American markets Understanding of managed care and reimbursement issues preferred

Education/Training:

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Bachelor’s degree required MBA (or other advanced degree) strongly preferred Bi-lingual (English/Spanish); knowledge of Portuguese desired

Other Requirements: Ideal candidate should live in US, in a major market with adequate airline service to

Latin America Willingness and ability to travel ~50% of time Highly motivated individual, able to be succeed in a rapidly changing, small company

environment Competencies

Strategic thinking Deep understanding of science and product development Oncology market expertise Cross-functional leadership Planning and organizational skills Team leadership, team development and team motivation

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Pharmaceuticals Job ID:4949413

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Apply on company website Director, Scientific Partnerships (US/ROW, New Txs, New Geography, New Products) Onyx Pharmaceuticals- Corporate Office - South San Francisco (San Francisco Bay Area) Job Description Summary The Director of Scientific Partnerships is responsible for global (US, EU and ROW) strategic initiatives with HCPs/investigators/thought leaders to include engagement plans, congress planning for KOL engagements, advisory boards and Investigator Forums. He/she will partner with corporate communication as a medical resource to the external advocacy groups and for associated activities. The candidate will act as a liaison to clinical and medical organizations to support the strategy including significant academic institutions, large community research sites and research cooperatives. The function may oversee IME/Grants that supports overall scientific strategy & communication. Essential/Primary Duties, Functions and Responsibilities Engage global thought leaders to develop advocacy, awareness, education and research for Onyx proteasome inhibitors (PIs) in current and emerging indications/disease states, new

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geographies and new products. (US/ROW (as defined as non EU new geographies – New tumors/indications, new products) Lead KOL Strategy to include a strategic plan, identification/profiling, individual engagement plans, congress KOL sub team and implementation of coordinated KOL engagements (Asia Pac, Americas/Canada, and expansion geographies)

Differentiate Onyx PIs as the preferred proteasome inhibitors and establish Onyx as the scientific partner of choice through innovative initiatives, coordinated strategy and scientific communication

Develop and oversee innovative programs that meet scientific interests for KOLs/investigators/key customers and Onyx (i.e. Visiting Professor Days to Onyx, INTERSECT program for Onyx to visit key centers, Global Investigator Forums in ROW or maybe EU, PRISM NTP (Novel Therapies Program) a global research collaboration to combine pipeline with novel compounds)

Create and integrate plans for cooperative groups and research networks in the US, Europe and in expansion geographies

Partner with Advocacy to develop strategic and tactical plan to include advocacy interactions and patient-aimed communication materials in close cooperation with the commercial and the Medical Affairs team.

Identify, prioritize and create an integrated global advisory board plan for advisory boards and similar forums for HCPs/Investigators/KOLs in the U.S. and Europe in collaboration with key internal constituents.

May oversee IME/Grants function and Grant Manager responsible for Grant Review Committee (GRC)

Responsible for collaboration across Development teams, Medical, MSLs and Scientific, Research, Product and marketing Teams to ensure the Cooperative Group plans and presence effectively support Onyx research Coop research plans.

Responsible for establishment of a regular and formal communication plan to ensure all appropriate functional groups are informed of status of Scientific Partnership programs such as Advisory Boards, Investigator Forums and Cooperative Group plans.

Conduct business in accordance with Onyx values Other Duties as assigned.

Desired Skills & Experience Work Experience:

Minimum of 5 years experience as a clinician and/or in clinical research. Minimum of 10 years in pharmaceutical industry Experience working directly with the Cooperative Groups/Research networks preferred Experience leading and managing advisory boards or similar forums highly desired Experience with Global and US initiatives as described for a minimum of 2 years highly

desired Medical and Scientific Affairs background as a focus is most relevant prior experience

Management of Staff: Management of Senior Grant Manager Functional/Technical Knowledge & Skills:

Proficiency with Excel and Power Point for budgeting, strategic planning and communication of departmental initiatives very important

Ability to champion ideas and communicate them clearly; Translate a vision and align multiple functions and levels

Customer & Industry Knowledge:

Knowledge and understanding of relevant clinical and therapeutic issues Ability to create and present on scientific and clinical data Proficient in scientific literature searches, analysis, and evaluation

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Knowledge on current regulatory and compliance standards Education/Training:

Strong science/clinical background with advanced degree preferred (e.g. MSN, Pharm.D., Ph.D.)

Therapeutic Focus/Experience: Oncology experience is preferred, Hematology experience highly desirable

Existing understanding or relationships in Myeloma, Hematology, and/or Small Cell Lung Cancer is extremely desirable

License/Certification Required: MD, PhD, PharmD preferred Other Requirements:

Strong science and clinical expertise specially in Oncology and/or Hematology Ability to work with little supervision with confidence Ability to handle multiple tasks under hectic, evolving environment Demonstrates ability to drive for results and to support team and corporate success

through technical expertise and broad-based business acumen Demonstrates ability to achieve outcomes through others utilizing a sound collaborative

approach Ability to Integrate functional expertise with business knowledge to develop optimal

solutions for complex problems Demonstrates sound analysis, strategy, decision making, and risk taking skills to

advance the business Demonstrates clear understanding and application of regulatory compliance

requirements Ability to prioritize and plan for development, best practices, and innovation Demonstrated ability to create and facilitate a positive environment by encouraging

leadership, respect, innovation, effective communication, and accountability Excellent interpersonal, leadership, and communication skills Willingness to travel (30-40%), globally and domestically, often on weekends

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:January 28, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Job ID:4494893

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http://www.linkedin.com/jobs?viewJob=&jobId=4891768&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3XbO7pB-ydiBE1

AR&D Associate Director GXP Search, LLC- Orange County, California Area Job Description

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The primary function for this position is to oversee analytical activities in R&D project group to support the development of niche generic products. This includes development and implementation of standards and methods in R&D Lab, scheduling and supervising group’s daily activities, selecting, developing and evaluating personnel to ensure the efficient operation of the function, supporting ANDA filings and deficiencies responses. Desired Skills & Experience •PhD with 8-10 years of experience in the pharmaceutical analytical chemistry or related sciences, with hands-on knowledge of current analytical techniques, and a proven supervisory experience. • Strong knowledge of FDA/ICH regulations. Company Description Top generic company in Southern CA. contact me for more information about this position..... Additional Information Posted:February 15, 2013 Type:Full-time Experience:Director Functions:Science Industries:Pharmaceuticals Job ID:4891768

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Posted by Everett Bracken, Chairman & CEO, VOLO Careers International - A Global Executive Recruiting Corporation

Senior Commercial Contracts Specialist (Location: Southern California) * Send Resume to RESUME@VOLOCareers.com

************************************************************** For the opportunity below, please send resume to Darshani at wd_darshana at hotmail dot com. Prototype Hardware-Firmware Design Engineer - SF, CA For the opportunity below, please send resume to wd_darshana at hotmail dot com. Various other opportunities are posted in JOBS category at the link below and include - Machine Learning Specialist, DSP Expert, Quality Engineer and more. Prototype Hardware-Firmware Design Engineer - SF, CA There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus. Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug,

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and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology. ****************************************************** Apply on company website Healthcare Educator: Northern CA Baxter Healthcare- Sacramento, California (Sacramento, California Area) Job Description We are looking for a bilingual Healthcare Educator based in Northern CA who will be responsible for supporting the sales and marketing efforts by providing bilingual (Spanish) health education to key Baxter accounts. This includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorders communities in No CA, WA and OR General Description 1 Provides support and professional expertise to internal and external customers by providing bilingual (Spanish) health education which includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorder community 2 Conducts outreach and educational programs and serves as a primary Spanish Language (SL) educator and consultant regarding the appropriate use of Baxter products and services to achieve business results 3 Identifies, designs and implements new consulting strategies as dictated by needs of the business and marketplace through collaboration with the sales account team to determine potential opportunities and how to accomplish sales objectives 4 Develop customer partnerships through customer needs analysis and develops strategies to advance SL education for the bleeding disorders community. 5 Mentors new and existing Bilingual Healthcare Educator, Clinical Consultants, Territory Business Managers, and Bleeding Disorders Managers by providing orientation, education and training on new and existing (SL) programs, tools and services and their applications. 6 Provides customer feedback and acts as a consultant to Sales, Marketing and other internal teams on designing and improving new/existing products and customer utilization needs. 7 Coordination/communication of activities and identification of issues across all teams that interface with the customer (i.e. clinical consultants, field service, sales, quality) in order to address issues within assigned responsibilities. 8 Demonstrates compliance with internal procedures, processes and values. The ideal candidate will possess the following background: 1 Bachelor's degree preferred, majoring in health care and /or social work arena. 2 Five years minimum experience in health education/social work and patient outreach in the Hispanic community. 3 Strong presentation and communication skills 4 Excellent English and Spanish written and verbal communication skills 5 Hemophilia or bleeding disorders experience preferred 6 Analytical and problem solving capability, along with ability to work independently 7 Ability to develop healthcare educational programs and customer strategies. 8 Strong interpersonal skills and ability to work with team members, customers and internal

3/3/2013 36

and external employees at all levels. 9 Travel required 50%, including nights and week-ends. Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V. Additional Information Posted:February 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Health Care Provider Industries:Pharmaceuticals Employer Job ID:58368BR Job ID:4775005 **************************************************** Apply on company website Nurse Educator - San Francisco, CA 4620 Quintiles- San Francisco, US-CA (San Francisco Bay Area) Job Description As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Nurse Educator to join our team of over 10,000 global field personnel supporting our pharmaceutical and biotech clients. Nurse Educator Patients are at the center of our business strategies. The Nurse Educator Program is an educational based program designed as a resource for patients living with auto-immune diseases that have been prescribed specific medications. Nurse Educators provide education about specific disease treatments, and resources to help patients better begin and manage their disease state and resources associated with their prescribed medication. Nurse Educators are responsible for participating in one-on-one communications with patients as well as appropriate medical professionals within the associated treatment process. Since the program is strictly educational based, Nurse Educators do not provide medical advice or work clinically within this role. The Nurse Educator will: · Coordinate and facilitate the connection between patients and program approved, patient based resources. · Provide direct educational training to patients on specific disease states, and assigned medication. · Develop local Patient Advocacy opportunities by creating and/or supporting existing community networks and educational forums · Support patient and provider educational speaker programs · Provide patient-focused education to promote behavioral change for the empowerment of patients to improve specific treatment compliance

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· Foster appropriate dialogue between patient and health care provider Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at: http://www.quintiles.com/ EOE Desired Skills & Experience Job Qualifications:

Bachelor’s degree Preferred BSN and/or RN licensure Current nursing license in good standing 5 + yrs clinical experience in healthcare to include hospital, homehealth ,

pharmaceutical or biotech Nurse educator experience preferred Direct interaction with patient and support for persistence and compliance Knowledge of clinical data and pharmacology Demonstrated time management skills; planning and prioritization skills; ability to

multi-task and maintain prioritization of key projects and deadlines Demonstrated effective presentation skills; ability to motivate others; excellent

interpersonal (written and verbal) skills – with demonstrated effectiveness to work cross-functional and independently

Demonstrated ability to develop, follow and execute developed plans in an independent environment

Demonstrated ability to effectively build positive relationships both internally & externally

Demonstrated ability to be adaptable to changing work environments and responsibilities

Fully competent in MS Office (Word, Excel, PowerPoint) and iPad technology Flexibility to work weekends and eveningAdditional Information

Posted:February 12, 2013 Type:Full-time Experience:Associate Functions:Other Industries:Hospital & Health Care, Medical Practice, Pharmaceuticals Compensation:0 Employer Job ID:1219709 Job ID:4860600 ******************************************************* Apply on company website Healthcare Educator: Northern CA Baxter Healthcare- Sacramento, California (Sacramento, California Area) Job Description We are looking for a bilingual Healthcare Educator based in Northern CA who will be responsible for supporting the sales and marketing efforts by providing bilingual (Spanish) health education to key Baxter accounts. This includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorders communities in No CA, WA and OR

3/3/2013 38

General Description 1 Provides support and professional expertise to internal and external customers by providing bilingual (Spanish) health education which includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorder community 2 Conducts outreach and educational programs and serves as a primary Spanish Language (SL) educator and consultant regarding the appropriate use of Baxter products and services to achieve business results 3 Identifies, designs and implements new consulting strategies as dictated by needs of the business and marketplace through collaboration with the sales account team to determine potential opportunities and how to accomplish sales objectives 4 Develop customer partnerships through customer needs analysis and develops strategies to advance SL education for the bleeding disorders community. 5 Mentors new and existing Bilingual Healthcare Educator, Clinical Consultants, Territory Business Managers, and Bleeding Disorders Managers by providing orientation, education and training on new and existing (SL) programs, tools and services and their applications. 6 Provides customer feedback and acts as a consultant to Sales, Marketing and other internal teams on designing and improving new/existing products and customer utilization needs. 7 Coordination/communication of activities and identification of issues across all teams that interface with the customer (i.e. clinical consultants, field service, sales, quality) in order to address issues within assigned responsibilities. 8 Demonstrates compliance with internal procedures, processes and values. The ideal candidate will possess the following background: 1 Bachelor's degree preferred, majoring in health care and /or social work arena. 2 Five years minimum experience in health education/social work and patient outreach in the Hispanic community. 3 Strong presentation and communication skills 4 Excellent English and Spanish written and verbal communication skills 5 Hemophilia or bleeding disorders experience preferred 6 Analytical and problem solving capability, along with ability to work independently 7 Ability to develop healthcare educational programs and customer strategies. 8 Strong interpersonal skills and ability to work with team members, customers and internal and external employees at all levels. 9 Travel required 50%, including nights and week-ends. Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.Additional Information Posted:February 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Health Care Provider Industries:Pharmaceuticals Employer Job ID:58368BR Job ID:4775005 ****************************************************** Started by Jon Hauptman, President, The Hauptman Group Healthcare Search Consultants

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APPLY DIRECT to www.thehauptmangroup.com Hospital Sales Rep - (Transplant) - San Francisco! Strong pharmaceutical sales organization is looking for a proven "top performer" with a documented track record of success within the Hospital setting. Candidate "MUST" have injectable experience. Transplant experience is a plus. Total Compensation $130k - $160k Salary, Uncapped Bonus! Company Car, Medical, Dental, GREAT 401k, Outstanding Package! MUST HAVE Qualifications: 4-Year Degree; 3 Years Pharma Sales with Current Hospital Sales Experience; Consistently Ranked within the Top 20% in the Nation; Injectables Experience Transplant experience helpful! Must have Strong Documentation and be HIGHLY Decorated with Documented Track Record of Exceeding Quota Top Performers, only - No job hoppers! ________________________________________________________ Specialty Pharma Rep (Pain) - San Jose! APPLY DIRECT to www.thehauptmangroup.com STRONG specialty pharmaceutical organization is looking for a proven "go-getter" who has a consistent track record of success within the pain management (pharma) arena. Must Have QUALIFICATIONS: 4-Year Degree 3+ Yrs Pharma Sales Relationships w/ Pain Management and/or Orthopedics preferred Decorated with Documented Track Record of Exceeding Sales Quota Top Performers, only! No job hoppers. Salary + Bonus : $100k - $130k Great Benefits: Car, Medical, Dental, GREAT 401k, etc.. **************************************************** Posted by Amanda Rosales, Recruiter at SMR Group Ltd Email resume to alan@smrgroupltd.com Looking for specialty pharma reps w/ demonstrable over quota sales success in San Francisco, CA, Cincinnati, OH, Atlanta East, GA, Los Angeles, CA, Towson, MD, Boston, MA, Knoxville, TN ___________________________________________________ Looking for specialty pharma reps w/ demonstrable over quota sales success in San Jose, CA, McAllen, TX, Hempstead-Melville, NY, Fargo, ND, New York, NY, Albany, GA, Lima, OH, Phoenix, AZ Email resume to alan@smrgroupltd.com __________________________________________________

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Looking for specialty pharma reps w/ demonstrable over quota sales success in Sacramento, CA, Arlington, VA, Denver, CO, El-Paso-Albuquerque, TX-NM, Morristown, NJ, Boise, ID, Newtown, PA, Miami, FL Email resume to alan@smrgroupltd.com _____________________________________________________________ Looking for primary care reps w/ demonstrable over quota sales success in South Bend, IN, Norwich, CT & Orange, CA. Email resume to alan@smrgroupltd.com ******************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-California-Biotechnology-Jobs-Careers-74698 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Clinical Research Associate / CRA Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Monitor one or more clinical trials 2) Participate in the design and writing of protocols, case report forms and informed consent forms for all clinical trials 3) Initiate and coordinate study start-up activities, including investigator identification and selection, contract and budget preparation, presentation at investigator meeting and vendor/investigator training 4) Take responsible for study management, including CRO, central lab and vendor management 5) Collect documents and generate supplemental material, including monitoring plans, data management plans and training materials 6) Ensure site evaluations, investigator meetings, study initiation, monitoring, closeout visits, review of case report forms, adverse event recording and reporting 7) Manage and ensure that the studies are conducted and adhere to FDA/ICH guidance on Good Clinical Practices (GCP) 8) Monitor investigator performance and ensure protocol compliance and patient safety 9) Ensure that Case Report Forms (CRFs) are reviewed, pulled in a timely manner and submitted to Data Management 10) Assist in writing and compilation of the clinical report for submission 11) Coordinate clinical supply requirements, shipping and key documentation with global R&D locations TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on

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Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151174698 Job ID:4935151 _____________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-84415 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Regulatory Affairs Associate / RA Associate Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Assist in reviewing and maintaining documentation associated with manufacturing and vendor qualifications 2) Coordinate and support the development of the finished product stability program 3) Assist in maintaining the R&D database 4) Represent R&D by offering technical assistance to multiple groups within the company, including quality control 5) Oversee regulations, research and current events in regards to product labels, product claims and nutritional values, and material issues 6) Maintain up-to-date knowledge of laws, regulations and policies enforced by the federal, and

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the state governments 7) Author submissions and other regulatory documents to obtain approval to bring new or modified products to market TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151184415 Job ID:4935128 ______________________________________________________ To apply, please use this link http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-R-AND-D-Science-California-Biotechnology-Jobs-Careers-86977 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer

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MS-WORD or plain text) Associate Director of Clinical Pharmacology Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Develop and maintain program specific and comprehensive clinical pharmacology strategic development plan 2) Prepare clinical pharmacology sections of regulatory documents and represent clinical pharmacology during interactions with regulatory agencies 3) Assist with co-ordination of key opinion leaders, consultants and other therapeutic area specialists in the drug development process 4) Participate in the drafting and finalization of clinical study protocols and study analysis plan (SAP) 5) Provide clinical pharmacology/pharmacokinetic subject matter expertise to the clinical study team/joint development team 6) Conduct pharmacokinetic analysis 7) Prepare external presentations and publication TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume.

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Additional Information Posted:February 21, 2013 Type:Full-time Experience:Director Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151186977 Job ID:4935097 ________________________________________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Quality-R-AND-D-Science-Laboratory-California-Biotechnology-Jobs-Careers-87456 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Sales Account Manager, Lab equipment ( Business Development ) Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Grow new accounts, identify new opportunities and build relationships to gain new business revenue for the company 2) Implement effective sales plans to position the organization competitively and meet / exceed territory objectives 3) Identify the needs of new prospects and develop appropriate responses 4) Perform field calls for the account and assigned territory 5) Participate and attend sales meetings and professional association meetings outside of regular business hours, as required 6) Build and maintain key alliances with distributors and field sales team 7) Communicate with all levels of management within both the distributor and field sales organization TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm

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We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151187456 Job ID:4935088 ************************************* Apply on company website Account Executive Veeva Systems- San Diego metro (Greater San Diego Area) Job Description Veeva Systems is looking for experienced Account Executives to drive sales for cloud-based solutions including CRM and Content Management applications into major life science organizations. As an Account Executive, you will be responsible for generating qualified opportunities, winning new business and managing relationships with large customers. Creativity, energy and the ability to work effectively within a growing team are critical. Qualified applicants should be in the United States in the MidAtlantic or Southern California. Ideal locations are in a metro area of New Jersey or Southern Cal / San Diego metro. Responsibilities:

Understand and present the Veeva products and inspire prospect interest Manage relationships with key stakeholders across business, IT, and C level Meet/exceed pipeline generation and revenue targets Manage complex sales cycles, utilizing internal and external resources as appropriate Be willing to travel

Desired Skills & Experience Requirements:

5-7 years experience selling enterprise software and related services into complex environments

Proven track record of meeting and exceeding sales quotas Experience selling into Top 30 Pharma/BioTech companies Strategic account planning and execution skills

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Must be highly self-motivated and able to work with little direct supervision Excellent oral and written communication skills A passion for solving people’s business problems 4 year degree required

Nice to Have: Strong understanding of content management challenges and CRM value in the life

sciences industry is desired. Company Description Veeva Systems is the leader in cloud-based business solutions for the global life sciences industry. Committed to innovation, product excellence and customer success, Veeva has over 150 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is a privately held company headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Budapest, Paris, Beijing, Shanghai and Tokyo. For more information, visit www.veevasystems.com. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales Industries:Computer Software, Pharmaceuticals Job ID:4950574 ***************************************************** Posted by Isabel Brito, Atlantic Management Resources Send resumes to ibrito@amrjobs.com We are looking for dedicated hospital sales reps in San Francisco or Sacramento We are looking for dedicated hospital sales reps in San Francisco or Sacramento who have 3+ years of top-performing hospital experience. Awesome opportunity to work for a small, growing specialty pharma company with plenty of room for upward mobility.

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http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=216743176&gid=61852&trk=eml-anet_dig-b_jb-ttl-cn&ut=2fSwJXsWxQi5E1

Posted by Allison Glogovac, Clinical & Scientific Recruiter at Bayside Solutions

Actively looking for a STAT PROGRAMMER for my Bay Area Client! ******************************************************** Apply on company website Director, Scientific Partnerships (US/ROW, New Txs, New Geography, New Products) Onyx Pharmaceuticals- Corporate Office - South San Francisco (San Francisco Bay Area) Job Description Summary The Director of Scientific Partnerships is responsible for global (US, EU and ROW) strategic initiatives with HCPs/investigators/thought leaders to include engagement plans, congress planning for KOL engagements, advisory boards and Investigator Forums. He/she will partner with corporate communication as a medical resource to the external advocacy groups and for

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associated activities. The candidate will act as a liaison to clinical and medical organizations to support the strategy including significant academic institutions, large community research sites and research cooperatives. The function may oversee IME/Grants that supports overall scientific strategy & communication. Essential/Primary Duties, Functions and Responsibilities Engage global thought leaders to develop advocacy, awareness, education and research for Onyx proteasome inhibitors (PIs) in current and emerging indications/disease states, new geographies and new products. (US/ROW (as defined as non EU new geographies – New tumors/indications, new products) Lead KOL Strategy to include a strategic plan, identification/profiling, individual engagement plans, congress KOL sub team and implementation of coordinated KOL engagements (Asia Pac, Americas/Canada, and expansion geographies)

Differentiate Onyx PIs as the preferred proteasome inhibitors and establish Onyx as the scientific partner of choice through innovative initiatives, coordinated strategy and scientific communication

Develop and oversee innovative programs that meet scientific interests for KOLs/investigators/key customers and Onyx (i.e. Visiting Professor Days to Onyx, INTERSECT program for Onyx to visit key centers, Global Investigator Forums in ROW or maybe EU, PRISM NTP (Novel Therapies Program) a global research collaboration to combine pipeline with novel compounds)

Create and integrate plans for cooperative groups and research networks in the US, Europe and in expansion geographies

Partner with Advocacy to develop strategic and tactical plan to include advocacy interactions and patient-aimed communication materials in close cooperation with the commercial and the Medical Affairs team.

Identify, prioritize and create an integrated global advisory board plan for advisory boards and similar forums for HCPs/Investigators/KOLs in the U.S. and Europe in collaboration with key internal constituents.

May oversee IME/Grants function and Grant Manager responsible for Grant Review Committee (GRC)

Responsible for collaboration across Development teams, Medical, MSLs and Scientific, Research, Product and marketing Teams to ensure the Cooperative Group plans and presence effectively support Onyx research Coop research plans.

Responsible for establishment of a regular and formal communication plan to ensure all appropriate functional groups are informed of status of Scientific Partnership programs such as Advisory Boards, Investigator Forums and Cooperative Group plans.

Conduct business in accordance with Onyx values Other Duties as assigned.

Desired Skills & Experience Work Experience:

Minimum of 5 years experience as a clinician and/or in clinical research. Minimum of 10 years in pharmaceutical industry Experience working directly with the Cooperative Groups/Research networks preferred Experience leading and managing advisory boards or similar forums highly desired Experience with Global and US initiatives as described for a minimum of 2 years highly

desired Medical and Scientific Affairs background as a focus is most relevant prior experience

Management of Staff: Management of Senior Grant Manager Functional/Technical Knowledge & Skills:

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Proficiency with Excel and Power Point for budgeting, strategic planning and communication of departmental initiatives very important

Ability to champion ideas and communicate them clearly; Translate a vision and align multiple functions and levels

Customer & Industry Knowledge:

Knowledge and understanding of relevant clinical and therapeutic issues Ability to create and present on scientific and clinical data Proficient in scientific literature searches, analysis, and evaluation Knowledge on current regulatory and compliance standards

Education/Training: Strong science/clinical background with advanced degree preferred (e.g. MSN,

Pharm.D., Ph.D.) Therapeutic Focus/Experience: Oncology experience is preferred, Hematology

experience highly desirable Existing understanding or relationships in Myeloma, Hematology, and/or Small Cell

Lung Cancer is extremely desirable License/Certification Required: MD, PhD, PharmD preferred Other Requirements:

Strong science and clinical expertise specially in Oncology and/or Hematology Ability to work with little supervision with confidence Ability to handle multiple tasks under hectic, evolving environment Demonstrates ability to drive for results and to support team and corporate success

through technical expertise and broad-based business acumen Demonstrates ability to achieve outcomes through others utilizing a sound collaborative

approach Ability to Integrate functional expertise with business knowledge to develop optimal

solutions for complex problems Demonstrates sound analysis, strategy, decision making, and risk taking skills to

advance the business Demonstrates clear understanding and application of regulatory compliance

requirements Ability to prioritize and plan for development, best practices, and innovation Demonstrated ability to create and facilitate a positive environment by encouraging

leadership, respect, innovation, effective communication, and accountability Excellent interpersonal, leadership, and communication skills Willingness to travel (30-40%), globally and domestically, often on weekends

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:January 28, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Job ID:4494893 *******************************************************

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To apply: Visit http://tinyurl.com/atswglj or www.BMRN.com CMC Project Manager (Clinical Product Lead) BioMarin- San Francisco Bay Area Job Description Job Description: The CMC Project Manager (Clinical Project Lead) will act as the single point person or single repository that tracks the many CMC-related activities on a product-by-product basis for several clinical product programs. The CMC Project Manager will track projects consistently and in detail using standard PMBOK practices and those project management practices associated with the BioMarin TPMG group .The CMC Project Manager will plan for the Technical Operations related activities, manage and track key clinical CMC activities, including identifying responsible individuals for completing; anticipate, resolve, and escalate issues; coordinate CMC plans with global development and forecasted commercialization plans and contribute to the development of a product portfolio view within Technical Operations. Job Responsibilities and Duties (including skill set needed/requirements):

Plan/manage/track key CMC activities, including identifying responsible individuals o DS, DP, API labeling/packaging o Regulatory submissions – including the tracking of INDs (and the comparable

filings on a country-by-country basis) approved in particular countries and the timing for introduction of clinical products

o Facility, equipment, IT systems requirements – in cases where implementation impacts specific product timelines

o Global distribution plans o Partner commitments, as appropriate o Contractor status – including the tracking-to-closure of CMO deviations

Develop a consistent methodology for managing CMC Subteams o Roles/responsibilities for team members, including defining appropriate

membership o Define decision-making authority for team and when to escalate o Consistent meeting management: agendas, desired outcomes, read-ahead

documents, minutes, etc. o Consistent use of project tracking tools (e.g., Primavera, MS Project,

dashboards, etc.) Anticipate, resolve, escalate issues as appropriate

o Scheduling conflicts o Technical issues o Processing issues o Compliance issues o Resource issues o Facility and equipment issues

Coordinate CMC project plans with global company plans o Galli and Shanbally production plans o Contract manufacturing production plans o Clinical development plans o CMC regulatory filings meeting o Assist with tracking project costs to be consistent with company budget

Coordinate CMC project plans with the other Portfolio Leaders o Clinical Product Lead o Commercial Product Lead o Portfolio Controllers and Master Controller

Develop a portfolio view of TOPS activities across clinical product programs along with other TOPS Product Leads and led by the head of TOPS Program Management.

o Allows for prioritization discussions across projects

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EEO/M/F/D/V Desired Skills & Experience Skill set required:

5+ years of experience with managing clinical pharmaceutical products from a project management, product development, process development and supply chain perspective.

5+ years experience within a Pharmaceutical Technical Operations group is required. Prior experience at building and developing schedules for CMC groups a must. A demonstrated ability to manage portfolio and project budgets A demonstrated ability to develop resource loaded and leveled plans A demonstrated ability of facilitating large cross-functional meetings within a

pharmaceutical setting is a must. Excellent interpersonal skills, including clear, succinct and timely communication and

proven ability to foster important relationships with customers and key stakeholders. The integrity and accuracy of project information to meet management requirements Partnering with the head of the Planning Management group in identifying, managing &

communicating key project risks and leading risk management strategies Working knowledge of project management practices either from a formal PMO

background or from extensive experience in managing projects or programs Bachelors Degree in a scientific discipline required. Advanced degree in science or

business preferred. - Project Management certification or equivalent is a plus (i.e.: PMP or equivalent Experience with Risk management practices an advantage).

Strong influence, negotiation, analytical and presentation skills. Ability to work effectively with cross-functional teams Ability to work in a highly matrixed organization with strong influence management

skills Extensive experience with MS Project or PrimaVera is a must. Extensive experience with Microsoft Office package, especially Excel and PowerPoint is

preferred. To apply: Visit http://tinyurl.com/atswglj or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. Additional Information Posted:February 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Strategy/Planning

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Industries:Biotechnology Job ID:4917543 ___________________________________________________________ Automation Engineer 1 – 2 To apply: Visit http://tinyurl.com/aw9ml7m or www.BMRN.com BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY • Final position offered will depend upon experience level of selected candidate. • Support existing control systems utilized in manufacturing operations, as well as support the design, engineering, and commissioning of new control systems. o Responsible for troubleshooting and problem-solving of manufacturing operations control systems/automation/instrumentation issues. This will include new installations, as well as replacement or upgrading of existing systems. o The position will require working closely with Facilities and manufacturing project managers (as part of project teams) to accomplish construction/installation. o This position will also require the development and implementation of system commissioning plans and interact with Validation on the qualification of these systems. • This position will require working with validated and non-validated systems. Modifications to validated system will require working within the Change Control program. RESPONSIBILITIES • Troubleshooting and problem-solving of existing manufacturing operations control systems/automation/instrumentation issues. Diagnose technical issues and provide recommendations/solutions for corrective actions. Follow established Quality Control systems. Review changes and assure appropriate documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans) are developed and on file. • Execute medium to high-level control systems projects/assignments in the support of site operations through investigations, control system assessments, and design support. Proactively look for and recommend improvements in site processes and procedures. • Working under direction of senior engineers, review, specify, design and/or install process control systems in direct support of commercial and clinical manufacturing operations. Create or review appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans, IQ/OQ). • Support and/or execute acceptance testing and IOQ protocols. • Maintain a library for vendor application software, historical data storage, back-up custom software applications, and required hardware needed for troubleshooting and maintenance. • Maintain support for building management systems (BMS) and other plant automation, including the design, implementation, and documentation of system changes. Interface with QA Validation group for GMP systems. • Assist with troubleshooting complex control system problems. Assure integrity of equipment operation as the result of troubleshooting or repair. Desired Skills & Experience EDUCATION • BS or MS Chemical, Electrical, or Mechanical Engineering from an accredited university. EXPERIENCE • Experience in PLC and data acquisition systems, building management systems (BMS), distributed control systems (DCS), mechanical operation of equipment, and process control are essential. • Experience with developing GAMP controls documentation for internal projects as well as reviewing/approving vendor supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans).

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• Allen-Bradley PLC hardware and software experience preferred (SLC, CompactLogix, ControlLogix, RSLogix500, RSLogix5000, and DeviceNet). • Experience with networks and communication protocols preferred. • Intellution iFix 4.5 SCADA experience preferred. • Intellution iBatch experience preferred. • DeltaV experience preferred. • Pi Historian experience preferred. • Virtual Machines experience preferred. • Strong organization, interpersonal, oral and written communication skills. • Minimum of 3 years experience with the installation, startup, and servicing of process control systems. • Minimum of 3 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment. • Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities strongly preferred. • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Access. To apply: Visit http://tinyurl.com/aw9ml7m or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. Additional Information Posted:February 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering Industries:Biotechnology Job ID:4917490 ********************************************************* ******************************************************** Apply on company website Director/Senior Director Marketing Medivation- San Francisco, Ca (San Francisco Bay Area) Job Description The Director/Senior Director of Marketing will lead the marketing team of Medivation’s first marketed product. This position reports to the VP of Marketing and will have at least 2 direct

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reports. This position offers the opportunity to join a team early in the evolution of product life cycle with a fully accrued Phase 3 study for the next indication ongoing. You will be a key contributor to the team in leading both strategic and tactical aspects of the promotional activities including advertising and promotional tactics, lifecycle management, PR, sales force communication and other brand marketing activities. This position must demonstrate an appreciation for strategic marketing with innovative approaches with a track record of success, as well as boundless energy and initiative. This role will require the ability to thrive in an environment of rapid change; a proven ability to work effectively within cross-functional teams as both a leader and a participant; will be highly innovative and creative as well as have the ability to inspire creativity and innovation in their team; and have a passion for science based brands that can dramatically improve patients' lives. Frequent exposure to high level executives both within Medivation and our partner company is expected so excellent communication skills and sound judgment are critical skills for success. This product is partnered with Astellas Pharma, Inc., a Japanese company with US headquarters near Chicago, IL. This position will have extensive contact with our partner company and maintaining our excellent relationship is a must. Desired Skills & Experience Essential duties & responsibilities but not limited to the following:

Good understanding of drug development/life-cycle management to help maximize the value of the product over the IP lifespan

Drive the integrated strategic and tactical commercial plans across a broad range of customer segments (health care provider, payer and patient) and markets (North America) to ensure an optimal and successful product launch.

Lead health care provider campaign including core visual aid, journal advertisement, educational leave-behinds, etc. whether in traditional or digital format

Provide regular executive management updates of promotion progress Responsible for utilizing primary and secondary market research to shape direction of

promotion, develop annual market research plan in partnership with market research team

Lead, motivate and develop direct reports Be known as a thoughtful, collaborative partner with Astellas. Anticipate and head off

problems caused by inefficient communications. Alert stakeholders internally to any potential issues or roadblocks that may jeopardize success of the product.

Perform all company business in accordance with regulations (e.g. EEO, FDA, OSHA, PDMA, EPA, PhRMA, etc.) and company policies and procedures, immediately reporting all noted/observed violations to management.

Requirements: Bachelor’s degree required. Graduate degree a plus. A successful track record with brand management, marketing team leadership, and

talent management Demonstrated expertise in marketing to diverse customer segments including

physicians, payers and consumers. Specialty markets experience a must. Documented experience in overseeing lifecycle management and market

development/expansion activities An understanding of the global reimbursement environment and drivers for value based

access with a focus on the U.S. Proven ability to successfully lead/work in a cross functional team setting (clinical,

medical affairs, sales, managed markets, regulatory, legal, R&D, project management) Demonstrates high ethical and professional standards with business contacts in order to

maintain Medivation’s excellent reputation within the biotech community

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Excellent communication and presentation skills, strong business acumen, analytical orientation, and ability to influence others

Demonstrated ability to create financial and operational objectives across business departments

Experience with a co-development or co-promotion product is a plus Ability to accommodate ~30% travel

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V Company Description Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publically traded biopharmaceutical company located in San Francisco. Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation’s goal is to transform the treatment of these diseases and offer hope to critically ill patients and their families. With the approval of Xtandi (enzalutamide) capsules in late August and the early September product launch immediately following, Medivation is in the process of building and developing a world-class workforce to take the company to the next strategic level. Additional Information Posted:February 4, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Pharmaceuticals Job ID:4787051 ****************************************************** Posted by Tim Flynn, PRC, CDR, CIR, ACIR, CSSR, Amgen Staffing Client Services Manager through The RightThing, Inc. an ADP Company Hiring - Regulatory Affairs Professionals - Southern San Francisco Apply Here - http://jobvite.com/m?34VtIfwU Join Onyx Pharmaceuticalshire.jobvite.com We're hiring for Associate Director, Regulatory Affairs - Emerging Markets, Director/Senior Director, Global Regulatory Lead, Associate Director/Director, Regulatory Affairs, Associate Director, Regulatory Affairs, Labeling,... ****************************************************** https://jobs.smartbrief.com/action/listing?listingid=463F74FC-A105-459E-BCEC-3825DF9093F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/8/13 Location: Irvine, CA Salary Range: Open

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Years Experience: 10 Director of Global Infrastructure - 002196 Edwards Lifesciences Job Description Leadership: * Achieve excellence in defining, developing and deploying business-centric IT solutions * Champion change and effectively manage the implementation of new ideas * Provide leadership and management over the Irvine Infrastructure team * Provide leadership and support for regional IT resources * Promote the company through attendance and speaking engagements at industry conferences or involvement in local business organizations Departmental Management: * Define, develop, present to management, gain acceptance and approval of ITLT or CIO a plan that is aligned and coherent with an overall Global IT strategy plan * Lead global implementations, and provide technical oversight to regional IT projects to ensure they are in-line with global standards * Work with RMs, stakeholders and regional IT resources to assess and respond to day-to-day business IT needs * Hold regular departmental meetings to review strategic goals and initiatives, promote teambuilding and work to provide growth paths for staff * Supervise the ongoing operations of the Desk Top Support providing quality and timely support to Edwards employees concerning hardware and software needs * Lead recruiting, hiring, on-boarding and training for IT support staff * Administer the department budget * Defines and enforces standard company policies and procedures as it relates to Global Infrastructure * Serve on planning and policy-making committees as required Teamwork: * Reinforce team approach to problem resolution, especially as it pertains to working with the global IT team * Support and solicit input from team members at all levels within the organization Client Management: * Communicate effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, with always an eye toward a single, global solution * Continually define ways to increase internal client satisfaction and deepen client relationships * Provide senior level resolution to internal and external client issues Infrastructure and Desktop solutions (Hardware and Software): * Establish global infrastructure and application solution standards * Identify emerging information technologies to be assimilated, integrated, and introduced within the regional infrastructure fabric * Oversee the commissioning of infrastructure to ensure that it is harmonized with global standards, so that Edwards employees always have the same experience, “anywhere, anytime” * Oversee the testing, selection and implementation of new desktop solutions and changes to existing solutions that are (1) global in nature; and (2) localized just enough to meet the statutory and regulatory requirements in the region * Serve as primary contact with outside vendors in the generation of RFPs, bids, contracts, agreements, and other major vendor interactions Systems Operations and Maintenance: * Oversee the integrity and continual operation of the global network, including LAN/WAN and data center services * Ensure the continual functioning of mission critical infrastructure, application solutions and operations * Maintain security and privacy of the information systems, communication lines, and equipment * Define, develop, review, and certify all back-up and disaster recovery procedures and plans * Oversee IT related aspects of all the regional construction and renovation projects Education, Skills and Abilities: * B.S. degree in computer science, computer engineering, electrical engineering or related field, a Master’s degree is a plus * Ten years management/leadership experience, including deployment and management of global infrastructure an on a large scale * Experience moving or building a data center is highly preferred * Strong analytical and logical problem solving skills * Strong interpersonal communication and relational skills * Proven organizational and project management skills, working in a satellite location of a multi-national corporation, preferably US-based * User-centered attitude and willing to work in a team oriented environment that serves a diverse population * At ease in a matrix organization * Speaks English as a first language * Possess and displays sound judgment; initiative; flexibility and detail-orientation

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********************************************************** For Further information and to apply please Call Tom Doyle at kppm in Dublin on: 01-2932220 or Email: tom@kppm.ie Process Engineers (For roles in San Diego USA) Process Engineers (For roles in San Diago USA) 1 x Senior Process Engineer (10+year's experience) and 1 x Intermediate Process Engineer (5+Year's Experience) Degree Qualified with strong Process Design Experience on Sterile Manufacturing Plants. This is to work within a Design Team working on Large and small plant expansion projects candidates who also have Installation through to Commissioning and Handover stage would have a distinct advantage. These are long term contract positions with excellent all-inclusive hourly rates and Return Flight packages. ******************************************************** Posted by Joanna Seidler Farber, ★ IT & Pharmaceutical Staffing/Recruiting (& Publishing Pro!) ★ Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindip@alphaconsulting.com *** HIRING *** Alpha Consulting Corp. is seeking a MANAGER / ASSOCIATE DIRECTOR, CLINICAL PHARMACOLOGY [ONCOLOGY] for its client to work in SAN DIEGO, CA *** W-2 CANDIDATES ONLY *** (13-00134) REQUIREMENT #13-00134 RECRUITER: CINDI PISNOY JOB LOCATION: SAN DIEGO, CA *** W-2 CANDIDATES ONLY! *** Project Description: Integrate drug metabolism, biopharmaceutics, and toxicology data to design clinical pharmacology study protocols for oncology compounds. Support a full development compound, design and writing clinical pharmacology study protocols, analysis plans and clinical reports, IBs, etc., and oversee clinical pharmacology aspects of clinical studies. Use standard PK software (eNCA and NonMem) to integrate PK and clinical data (PD) to evaluate optimal doses/regimens, analyze study results, draft Clin Pharm or clinical reports and provide quality control of analyses. Evaluate and apply new clinical data and data analyses to refine studies in development plan. Actively participate within the group to assist in meeting timelines by providing the requested data analyses, and work closely with the Clinical Pharmacology Team Leader in charge of the program. Responsibilities: • Design and implement a clinical pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates is rapidly achieved in the U.S., EU, Asia and throughout the world • Design and conduct clinical pharmacology studies such as drug-drug interaction, special population, and bioequivalence studies • Design dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients • Summarize and interpret results of clinical pharmacology studies and pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs • Use innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosing

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regimens, and study designs throughout clinical drug development • Evaluate and apply new techniques in PK/PD data analysis that improve information quality and utility, and enhance productivity • Design study protocols, analyze PK/PD data, and interpret results to meet the objectives of the Clinical Pharmacology Plan • Provide expertise to the Asset Team and the Clinical Sub-Team to optimize dose, dosing regimen, study designs, and strategy based on exposure-response information • Plan and direct clinical pharmacology components of clinical programs and studies • Lead multifunctional study team to design, deliver, and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies. Conduct regulatory-level non-compartmental analysis on data and takes scientific lead on clinical study report contribution • Deliver a drug interaction plan based on pharmacokinetic (e.g. metabolism, transporters) and pharmacodynamic properties of the candidate, as well as the medical/commercial needs • Summarize results of PK/PD analyses in Clinical Study Reports (CSR) and publish in peer-reviewed journals Qualifications: • Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, or related discipline • 4-8 years of postgraduate experience in clinical pharmacology, pharmacokinetic, and/or pharmacodynamic research in industrial setting • Clinical drug development, oncology drug development, and proven record of leadership Technical Skill Requirements: • Demonstrates thorough understanding of the following: 1) principles of PK, PK/PD 2) data analysis using non-compartmental and model-based PK and PK/PD methods 3) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology, and therapeutics especially oncology This PERMANENT position starts ASAP. ************************************************** Interested candidates can contact Nancy Symonds for more information (njs@nancysymonds.com). QUALITY CONTROL DIRECTOR - S. CALIFORNIA This position is located in Orange County and will have oversight for 25 staff, 4 direct reports. We are looking for strong management/leadership skills and expertise in analytical methods development. Must have biologics experience. Will report to VP Quality.Relocation assistance provided. Will relo nationwide. Your referrals are appreciated. Summary Responsible for the overseeing the Analytical Methods, Quality Control, Stability and Microbiology functions ensuring the manufacture and release of quality products and conformance to regulatory guidelines. Essential Duties and Responsibilities include the following. Other duties may be assigned. Quality Control Responsibilities: • Provide leadership to oversee and assure the activities of quality control systems, and

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laboratories in all areas are efficient, effective for internal and external customers and within the highest conformance to regulatory guidelines • Make recommendations for process improvement and corrective action to assure that the operations are ready for future manufacturing and customer projects. • Manage timelines and resources effectively to meet client and internal timelines with resources available. • Familiar with SOPs, Test Methods and validation protocols and has the knowledge to write and execute new developmental activities. Use of technical proficiency, scientific creativity, independent thought and collaboration with others to solve bioanalytical assay related problems. • Collaborate with Company's personnel/departments in order to meet internal/external customer requirements. • Assist with several other Quality System functions in order to maintain Good Manufacturing Practice (GMP). Supervisory Responsibilities Manage/direct the selection, training, motivation, development, appraisal and work assignments for QC personnel. Oversee a staff of approximately 20-25 QC technicians and 4 QC Managers. Education and/or Experience BS in Biochemisty, Chemistry, or related science with a minimum of 10 years related experience, training; or equivalent combination of education and experience. Experience with biologics products is required, preferably derived from mammalian cell culture. Must have experience supervising/managing QC functions in a cGMP environment. Must have knowledge of cGMPs, 21CFR210-211, ISO 14644, Federal Std 209-E. Experience in writing and executing IQ, OQ, PQ required. Experience in Regulatory Compliance Inspections required. Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines required. **************************************************************** Posted by Tim Flynn, PRC, CDR, CIR, ACIR, CSSR, Amgen Staffing Client Services Manager through The RightThing, Inc. an ADP Company Hiring for Sr Biopharmaceutical Rep, Oncology - Pasadena, CA at Pasadena -California and is looking for suitable candidates. I am using wisestep.com to share my jobs on Multiple Linkedin Groups with a single click. Apply Online http://www.wisestep.com/RSFTYWTX/IRIGKORRQR or Refer Friends who will love to take it. Job Description: Territory#18623 Pasadena, CA covering , CA: West to Burbank, East to Loma Linda, South to downtown Los Angeles, North to BakersfieldAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgens products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and

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territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelors degree & 2 years of sales experience OR Associates degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelors degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact ******************************************************* Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Project Coordinator Now hiring: Clinical Project Coordinator http://www.ziprecruiter.com/job/Clinical-Project-Coordinator/d6c54142/?source=social-linkedin-group-jobs ****************************************************** Posted by Elizabeth Rountree, Biotech Consultant Please send your cover letter/resumes to: sfresumes@c1consulting.com Manager Position at C1 Consulting (San Francisco) C1 Consulting is seeking an experienced Manager (7+ years of relevant experience) for the San Francisco office. C1 stands for "Customer's First" and successful candidates for this position are passionate about problem solving and enjoy working directly with clients to meet their business objectives. The position has four core components: 1) Client Management: Manage the client relationship for one or more clients. This aspect of the role includes business development/generating new projects as well as management of sold projects to ensure high client satisfaction. 2) Project Leadership: The Manager will be expected to be a "hands on" member of each project team and provide direction to ensure that the project meets client needs and business objectives, that the design, analysis, and deliverables are of the highest quality, and that team members have a clear understanding of their roles and responsibilities. Most Managers at C1 are also involved in moderating qualitative interviews (with our customers, Key Opinion Leaders, physicians, patients, and other stakeholders) on consulting and market research projects. Travel to client meetings, conferences, and market research is common - though much less than in traditional management consulting. 3) People Management: This position will have multiple direct reports and will be actively involved in staff professional development and mentoring. As a small firm, C1 relies heavily on on-the-job learning. Managers work closely with their direct reports to provide training and advice on client projects, develop professional development goals, provide career guidance, and evaluate performance. 4) Company Development: C1 is a small, dynamic consulting firm and each C1 team member has a role in making our company stronger. This position will be responsible for leading an important strategic initiative which may be internally focused or externally focused, depending

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on skills and interests. C1 projects are most often staffed with two to four team members. Working with small teams creates a close working relationship with other C1 team members and clients. Direct involvement of all team members with clients enables a better understanding of their needs and how project results and insights get used. C1 is a dynamic and growing company. The Manager position offers significant opportunity for growth. Desired Profile Ideal candidates for the position are graduates of top Masters or PhD programs with a minimum of 7 years of relevant work experience in pharmaceutical/biotechnology marketing, market research, or consulting. Candidates with more experience (12+ years) may be considered for a Director position. Candidates must have a strong analytic background and possess a clear understanding of the drug and/or medical device and/or diagnostic commercialization, forecasting, marketing and sales processes, and also have the ability to recommend creative methods to address clients’ objectives, interpret complex data, and draw key implications from results. In addition to strong educational background and work experience, we evaluate the following qualities when reviewing Manager candidates: • Passion for problem solving • Attention to detail • Exceptional work ethic • Good communication skills • Effective working in teams • Strong leadership Permanent U.S. Employment Authorization required. ******************************************************** Posted by Giovanni Lauricella, Medical Device Search Consultant at The Mullings Group VP of Medical & Clinical Affairs – Bay Area – Hematology Biologics/Device Ground breaking biologic company based in the Bay has discovered a proactive procedure for blood transfusion. We are looking for a VP of Medical & Clinical Affairs. Must have: • MD degree • Phase III clinical trial experience • Willing to travel 30% internationally • Hematology or oncology experience I would like to share more information with you. Please send me a copy of your resume to Giovanni@MullingsGroup.com ************************************************************* Posted by Jeff Randles, Account Manager - Sr. Recruiter at Precept Life Sciences

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Contract Regional CRA in Los Angeles, CA Now hiring: Contract Regional CRA in Los Angeles, CA http://www.ziprecruiter.com/job/Contract-Regional-CRA-in-Los-Angeles-CA/bd74e788/?source=social-linkedin-group-jobs ***************************************************** Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Trials Manager Now hiring: Clinical Trials Manager http://www.ziprecruiter.com/job/Clinical-Trials-Manager/e25f445c/?source=social-linkedin-group-jobs *********************************************************** Posted by Isabel Brito, Atlantic Management Resources Please send resumes to ibrito@amrjobs.com Looking for top-performing, entrepreneurial women's health/OBGYN sales representatives in Glendale, CA. Looking for top-performing, entrepreneurial women's health/OBGYN sales representatives in Glendale, CA. Must have at least 2 years of current, related experience. This is a fun opportunity to work for a small, growing company. ************************************************************** Posted by Mohammed Nadeem, HR http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=215307304&gid=61852&trk=eml-anet_dig-b_jb-ttl-cn&ut=0cl-7BPckCilE1 Job**Job**Job as CASE MANAGER at South San Francisco,CA.Skills: Healthcare reimbursement,benefit investigation, payor reimbursement policies,reimbursement support.Pls send resume to ... Looking for a Case Manager in South San Francisco, CA Provides customer focused reimbursement support to patients, distributors, physicians and internal sales force. Educates, informs, and assists patients and providers to navigate through the reimbursement process. Identifies barriers to reimbursement and continually identifies and recommends program efficiencies to the team to promote high quality of work by Access Solutions/GATCF staff. Identifies and facilitates referrals to alternative coverage options and financial assistance programs for patients who are under insured or require copy assistance. Skills: 3 years experience in Healthcare reimbursement. Must have proven outstanding customer service experience. Proficient in all aspects of reimbursement (i.e. benefit investigation, payor reimbursement policies). Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format. Ability to work collaboratively in a team structure and responsibly delegates next steps to appropriate team members. Demonstrates effective problem solving and excellent customer service. Exceptional attention to detail and ability to prioritize tasks. Requires computers skills including MS Excel. Education:

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BA or BS degree REQUIRED. http://bull.hn/l/10S5B/ ********************************************************

Jobs that Crossed My Desk Through Feb. 16, 2013 ******************************************************* Apply on company website Resource Manager - can also be known as Staffer, Location Manager or Staff Coordinator IMS Consulting Group- Bay Area (San Francisco Bay Area) Job Description Operating as a US Resource/Staffing Manager within the global resourcing team, to ensure the effective deployment of US West-Coast based consulting delivery team onto projects, business development opportunities and internal IMS Consulting Group initiatives. Through resourcing decisions, support the effective onboarding, development and retention of US based Consulting delivery team members. Principal Accountabilities:

Identify and resource West Coast consulting team members to client projects, business development opportunities, thought leadership and IMS Consulting Group internal initiatives.

Collaborate effectively with global resource management team todeploy consulting delivery team members in a manner that optimizes overall productivity while meeting individual development objectives.

Engage with the principals and other senior leaders to understand, plan for and ultimately meet the resourcing/staffing demands of their pipeline.

Enable and support development goals of West Coast analyst consulting delivery team through resource management decisions.

Monitor and communicate current and planned delivery capacity Maintain resource management data integrity in the PSA system that supports resource

and project management decisions Identify resourcing capability gaps in the analyst to senior consultant team as an input

to hiring and to support the development of training plans. Actively participate in the annual review process, providing insight to consultant

development and career progression Act as point of contact for training and other career opportunities

Desired Skills & Experience Bachelors degree or equivalent Prior resourcing or consulting delivery experience in a professional services environment Proven problem-solving skills with attention to detail Strong written and verbal communication skills Ability to build strong business relationships and influence with key stakeholders at all

levels within the business Excellent team-based interpersonal skills with ability to work independently Ability to demonstrate determination, diplomacy and resilience Ability to rapidly assimilate multiple types of information from a variety of sources for

effective decision making Proficient in Microsoft Office applications Knowledge of life science consulting is a plus

Company Description IMS Consulting Group is the world’s leading, specialized advisor on critical business issues in the life sciences, and is the management consulting arm of IMS Health, a leading provider of information, services and technology for the healthcare industry in 100+ countries around the

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world. Our IMS Consulting Group teams offer end-to-end management consulting in key issues areas that include: business unit, therapy area and brand strategy, portfolio strategy, launch strategy, pricing & market access studies and commercial model design and optimization. IMS Consulting Group is an Equal Opportunity Employer.We cultivate a diverse corporate culture across the 100+ countries where we operate, celebrating and rewarding teamwork and inclusiveness. By embracing our differences, we create innovative solutions that are good for IMS, our clients, and the advancement of healthcare everywhere. Additional Information Posted:January 23, 2013 Type:Full-time Experience:Mid-Senior level Functions:Management Industries:Management Consulting Job ID:4683292 ********************************************************** Posted by Jennifer Harvey, HR, Veracyte

Client Services Specialist

Now hiring: Client Services Specialist http://www.ziprecruiter.com/job/Client-Services-Specialist/be42a8fa/?source=social-linkedin-group-jobs

______________________________________________________ Medical Billing Specialist - Temp Position

Now hiring: Medical Billing Specialist - Temp Position http://www.ziprecruiter.com/job/Medical-Billing-Specialist-Temp-Position/0bff4c8d/?source=social-linkedin-group-jobs

********************************************************** Posted by Pharmalink Consulting - San Diego Director of Regulatory Affairs Pharmalink Consulting- San Diego (Greater San Diego Area) Job Description Our client is seeking a Consultant at the Director level for a long term project. As Regulatory Affairs Director at this successful and established pharmaceutical company, your responsibilities will include: • Leading regulatory affairs sub team and creating Global Regulatory Affairs Strategic Plan. • Coordinate global submission activities, lead global/regional submission activities • Providing strategic input into product lifecycle plans and maintain licences for marketed products. • Becoming the day to day contact point with regulatory authorities for communications relating to assigned projects. • Managing and coordinating requests for scientific advice with regulatory agencies. • Directing regulatory strategy and contributing to its outcome for assigned projects. Desired Skills & Experience • 7+ years of regulatory experience and a good understanding of US regulatory processes.

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• Biotech experience is preferred but not required. • Extensive submissions experience. • Excellent leadership and people management skills. • Ability to manage multiple projects and tasks. • Life sciences degree. • Good knowledge of the global regulatory environment. • Ability to direct regulatory strategy and contribute to its outcome when necessary Company Description Pharmalink Consulting is the No 1 choice for sustainable outsourcing for all Regulatory Affairs requirements. We can resource any Regulatory Affairs project – regardless of size and timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world. Unlike some other consultancies, Pharmalink specialises in Regulatory Affairs only. The business has become so specialised in the last 10-15 years, it requires dedicated teams of Consultants to meet the increasingly complex demands of local health authorities and keep abreast of all the changes that are constantly happening on a global and local market level. For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com Additional Information Posted:February 12, 2013 Type:Contract Experience:Director Functions:Consulting Industries:Pharmaceuticals Job ID:4861120 ******************************************************* Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this job. Associate Director Clinical Operations – Full Time Position (San Francisco Bay Area) PPBI To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. SUMMARY: The Associate Director, CTM will be responsible for the successful execution of Clinical Trials when outsourced to strategic CRO partners and Clinical Trial Management infrastructure deliverables. This individual will work in partnership with Medical Directors, Regulatory, Biostatistics, Research Directors and, critically, external partners. As a leader within the organization, the incumbent will be instrumental in the concept, design, growth and deliverables of the clinical trial management function as it relates to external partnerships to assure the highest quality delivery of Clinical Programs, on time and within budget. JOB RESPONSIBILITIES: • Support the Senior Director, Clinical Operations in clinical trial execution with external partners. • Manage clinical operations staff. • Act as operational lead for relationships with CROs where a strategic partner is in place. • Achieve clinical trial program execution within budget, on time, and of the highest quality, through cross-company and cross-partnership collaboration. • Identify and communicate clinical development risks and mitigation strategies as they relate to strategic partners. • Partner with the organization to optimize cross-functional communication.

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• Act as a lead for process optimization between CRO partners. • Assess and allocate resources for clinical projects; establish a systematic scalable approach for future project and portfolio enhancement based on risk management principles. • Support integration of Company and CRO teams and process to enhance success of new collaborations. EXPERIENCE AND QUALIFICATIONS: • Advanced degree in science or equivalent combination of relevant educational and professional experience is required; prior research and / or clinical training is desired. • Minimum of 10 years of experience and success in a clinical project/ trial management role within another biotech / pharmaceutical company, which shall include at least 3 years of experience working with CRO partnership. • Late stage clinical trial experience (Phase 3 or 4) preferred. • Direct Management experience of clinical operations personnel. Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com ******************************************************* Posted by Shelly Glasgow, Technical Recruiter at ProPharma Group Quality Engineer (APR) Consultant - Bay area Now hiring: Multiple Quality Engineer (APR) Consultants - Bay area. For immediate consideration, apply online at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Quality-Engineer-APR-Consultant-Bay-area/3a2c7d30/?source=social-linkedin-group-jobs ****************************************************** Posted by Shelly Glasgow, Technical Recruiter at ProPharma Group Quality Engineer (APR) Consultant - Bay area Now hiring: Multiple Quality Engineer (APR) Consultants - Bay area. For immediate consideration, apply online at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Quality-Engineer-APR-Consultant-Bay-area/3a2c7d30/?source=social-linkedin-group-jobs ****************************************************** If you are qualified and interested please contact me privately at dave@alpinesearch.net, or pass this information along to others as appropriate. Thanks- Dave Murphy The Alpine Group Associate Director of Marketing - SF Bay area A client of mine in the pharma business has asked me to help them fill a new marketing position at the AD level, responsible for inline brand managment and lifescycle planning in the CNS market. With the accelerating contraction of the pharma business it's increasingly rare to find companies willing to go external to fill AD / Director / VP roles but that's the case here. You will lead a small team of 2-3 Product Managers and the organization has doubled sales in the past two years so opportunity abounds for career development. Requirements include: 6+ years of marketing / brand management experience in the pharmaceutical industry Experience supervising other marketing personnel Pharmaceutical sales experience Bachelor's degree or better; MBA preferred

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Strong interest in working for a small to mid-size organization where the teams are small and the duties vary considerably ****************************************************** http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=213500934&gid=61852&trk=eml-anet_dig-b_nd-pst_ttle-cn&ut=2QSluhCaHd7lE1 Started by Lisa De Benedittis Biotech / Pharma Recruiter, Biotech, Pharmaceutical, Medical Device Recruiter @ Elite Recruiting Services, Inc. Chief Medical Officer, Hematology / Oncology - Biopharma - So. CA Chief Medical Officer, Hematology / Oncology - Biopharmaelitestaffingsvc.com Chief Medical Officer, Hematology / Oncology The Chief Medical Officer will provide hands-on leadership on the hematology and oncology medical strategy and drive execution of key deliverables The CMO will be responsible for... ****************************************************** Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Contact cheryl@biophaseinc.com if interested! Packaging Technician (Santa Clara, 6 months temp, $14-15/hr) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Packaging Technician to work for a leading Bay Area biotechnology company. Packaging Technician (Santa Clara, 6 months, $14-15/hr) This position is responsible for manufacturing and assembling products as required by the production schedule. Included are all production reagents which form the kit components, from the raw materials through to bottled and labeled finished goods. Capable at change-over and operation of all labeling and packaging equipment. Prints computer generated labels. Responsible for mastering all existing and new packaging equipment and processes to bottle, label, and package product, including the printing of computer generated labels. Follows appropriate guidelines established by the Manufacturing Process Instructions (MPI), Standard Operating Procedures (SOP), Equipment Operating Procedures (SOP) and Process Guidelines (PG). Satisfy due dates as specified in the Master Schedule with high quality product at or below cost targets. Works closely with QC, Reagent Chemistry, Materials and other production persons for work order priority, materials needs, line clearances, and work order completion. Ensures final components meet specifications working closely with QC and other production persons. Conducts in-process checks of packaged product as required. Assists in the training of new hires and temporary employees in the production process. Maintains an orderly and clean working environment Familiarity with basic laboratory devices and equipment plus some mechanical aptitude. Mathematical computation is necessary to compile data for completing batch records. Good oral and written communication skills, organizational abilities, flexibility, attention to detail and positive interpersonal skills are essential to this position. Must be able to use a computer and have a working knowledge of Microsoft Office and Excel. Local candidates only will be considered at this time. If you are not local but plan to relocate, please let us know.

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Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. ******************************************************* Posted by Gregg Baker, INSOURCE GROUP (812-430-8927), SEARCH CONSULTING, LION (I Never IDK); Among top 1% most viewed Profiles in 2012. If this describes you and you would like to investigate this opportunity in more detail, please contact me at gregory.baker@wowway.com or 812-430-8927. Strategic Account Service Delivery Manager - Southern California In this strategic Big Pharma Account, my client's strategic account service delivery manager oversees the presentation of services to clients while making sure the service levels are effective. They provide the crucial communications link between the customer's senior managers and the service operation which includes 70+ FTE. The successful candidate will provide account management leadership for a key account's analytical instrument laboratory asset management. They will provide the leadership required exceed the customer's service performance measures and deliverables and will anticipate customer needs, investigate underlying causes and identify short term or long term solutions. Ideally, you will have experience as a analytical instrument field service engineer (for Thermo, PerkinElmer, Bruker, Shimadzu, AB Sciex, Waters, Quest Diagnostics or comparable companies), then moved on to a managerial role in service delivery to a set of accounts or key accounts for laboratory asset management projects. **************************************************** Posted by Taylor Langston, Social Media & Sales Support Specialist at PharmacyWeek, Inc. Pharmacy Clinical Informaticist, Salinas Valley Mem Hlth Sys, Salinas, CA CPS http://www.pharmacyweek.com/job_seeker/listings/listing.asp?listing_id=14788&location_id=72767 _________________________________________________ Pharmacist (Program Specialist-Procurement), Department Of Veterans Affairs, Palo Alto, CA http://www.pharmacyweek.com/job_seeker/listings/listing.asp?listing_id=15001&location_id=72294 ******************************************************* Started by Jon Hauptman, President, The Hauptman Group Healthcare Search Consultants Specialty Pharma Rep (Pain) Positions- San Jose, San Diego, Bakersfield, Valencia, Phoenix! APPLY DIRECT to www.thehauptmangroup.com STRONG specialty pharmaceutical organization is looking for a proven "go-getter" who has a consistent track record of success within the pain management (pharma) arena. Must Have QUALIFICATIONS: 4-Year Degree 3+ Yrs Pharma Sales Relationships w/ Pain Management and/or Orthopedics preferred

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Decorated with Documented Track Record of Exceeding Sales Quota Top Performers, only! No job hoppers. Salary + Bonus : $100k - $130k Great Benefits: Car, Medical, Dental, GREAT 401k, etc.. Specialty Pharma Rep - San Josepcrecruiter.net *********************************************************** https://jobs.smartbrief.com/action/listing?listingid=57BFCAE2-207D-40D8-A067-60343ED6CC7C&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Sr. QA Manager - Quality Systems (Santa Barbara) Allergan Job Description Responsible for Quality System Harmonization Project while ensuring compliance of Allergan Medical’s Quality System with 21 Part 820, Part 11, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive), Canadian Medical Devices Regulations, and other applicable international regulations. Responsible for monitoring and improving Quality System processes, and leading quality system integration among multiple Allergan Medical locations, including evaluating processes and writing procedures. Manage the Allergan Medical Quality System Harmonization Project and function as the main liaison with Allergan management and site leaders. Establish detailed project timelines & tasks, including review points. Provide technical expertiseOversee activities and inputs/outputs of other team members. Create external requirements matrix. Generate matrices. Review QS documentation -determine compliance status and needed. Create or advise on needed remediation (process analysis, SOP creation). Monitor ongoing project status and day-to-day management. Responsible for issue/risk management. Authorized to stop/modify project activities. Responsible for tracking project budget.

Bachelor’s degree in engineering, sciences, or business. MS in engineering, sciences or business administration (MBA) is preferred. ASQ Certification is desired. Six (6) years of experience in Quality or Manufacturing within the Medical Device

industry. Additional four (4) years in Quality Management. Minimum of 10 years analyzing regulations and writing procedures and developing

processes and quality systems, affecting multiple locations. Knowledge of the listed regulations/standards is required: FDA’s 21 CFR Part 820

(Quality System Regulation), CFR Part 806 Medical Device Reporting, and 21 CFR Part 11 (Electronic Records; Electronic Signatures), ISO 13485:2003, Council Directive 93/42/EEC June, 1993 (Medical Device Directive), and the Canadian Medical Device Regulations, ISO 14971 (Risk Management).

Essential Skills and Abilities Demonstrated ability to lead a technical team. Demonstrated ability to make effective and timely decisions related to quality,

technical, and business issues with high risk or consequences to a business area. Excellent written and verbal communication skills. Effectively communicates both up and down the organization and maintains a customer

focus. Previous experience with Ministry of Health (MOH) inspections and responses. Previous experience in conducting FDA regulated recalls or field corrections. Excellent planning and prioritization skills with the ability to multi-task and adapt.

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Ability to identify, define and resolve problems using a structured methodology such as KTA.

Ability to analyze training needs. Ability to guide and delegate to subordinates.

******************************************************** https://jobs.smartbrief.com/action/listing?listingid=204F07A8-2717-45A8-9302-175B0507664F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Engineer, Process Development ArthroCare Corporation Job Description

Engineer, Process Development Irvine, CA

ArthroCare Corporation (Nasdaq:ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation(R) technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS(R) line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology. Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development. Summary: Design, Develop, Implement and Maintain Manufacturing Processes for assigned ArthroCare lines of products (devices). Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)

Responsible for developing and implementing new processes on new products and be the M.E. representative on development teams for designing, developing, implementing, and maintaining assembly, test, and packaging processes. Ensures that time lines, cost and quality expectations are met.

Develop new techniques for assembly and test, including test fixtures, with DOE and validating new processes, evaluate failure data from field to find root cause and implement sound engineering solutions.

Responsible for training techs and assemblers and supporting transfer of product into manufacturing facilities.

Provide accurate tracking and reporting on this activity. Provide continuous engineering support on assigned products to maintain and improve

margin, performance and quality. Work with R&D team leader to deliver acceptable documentation on product (including

but not limited to: Assembly and test fixtures, Routers, MPI, Test methods, Drawings and Specs) in a timely manner.

Participate and Manage (as required) engineering builds, verification and validation builds, and provide technical data/ report to the team leader.

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Ensure compliance with ArthroCare quality system and all relevant internal procedures and policies (including but not limited to: ECN, NCR, CPR, BOM, Router, MPI/ SOP).

Work on cost reduction projects to reduce material/ process costs by defining and implementing new techniques and equipment/ fixtures for assembly and test. This may require designing fixtures and implementing in manufacturing facilities.

Assist and lead product and process transfers to Costa Rica manufacturing facility. Supervisory Responsibilities: Technicians and/ or clean room personnel as required Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Education and/or Experience:

Essential. B.S. or M.S. degree in Engineering. At least 3 years in related field. Prefer experience in medical and surgical devices, and implantable biomaterials.

Language Skills: Excellent communication skills, and problem solving skills. Ability to plan and schedule multiple projects and tasks. Fluent in Spanish a plus. Mathematical Skills: Needed for engineering position Reasoning Ability: Need to be able to make rapid and sound decisions Computer Skills: Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works. Certificates, Licenses, Registrations: None Other Skills and Abilities: Be able to work with people at all levels of organization and understanding of MRP and document control software. Other Qualifications: Assembly and test fixture designing skills. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.

For consideration of this position and other opportunities please visit our career center at: http://careers.arthrocare.com

Equal Opportunity Employer

www.ArthroCare.com Requirements: Site for Posting English Required Expertise Engineering - Process Development Type of Job Full Time Work Location(s) CA - Irvine Required Years of Experience 3-5 Years ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=AB355F96-80F8-44D4-A925-7DA25F973B50&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 DIR OPERATIONS, Milpitas Site - 130000007R Abbott Job Description The Director of Operations is responsible for managing the planning, development, implementation, and maintenance of the operations at the AMO Milpitas site. This includes overseeing production, manufacturing, processes, and operations for new and existing products through subordinate management personnel. Will direct the strategies and tactics of the site including matrix management of a broad multi-disciplined organization and providing direction and leadership. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Responsible for implementing and maintaining the effectiveness of the quality systems. 2. Directs the AMO Milpitas Site and Manufacturing Operations, and is responsible for all major

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Compliance systems (Quality, Procurement, Production, EHS, Scheduling, Costs) used in insuring the marketplace receives world-class products (Phacoemulsification Systems, Excimer Laser Systems, Femtosecond Laser Systems, Ophthalmic Diagnostic Systems) at a competitive cost and on-time. 3. Will lead Milpitas Site; but must work effectively with peer leaders in Global Operations and with other key functions within AMO (Quality, Regulatory, Legal, HR, R&D, Finance, Sales & Marketing) to obtain world-class results. 4. Will develop the strategic, capital, and business plans, including annual budgets for Operations to assure attainment of Standard Costs targets, Quality & Reliability targets, Capital targets, New Product Introduction targets, and Inventory targets. 5. Drives development and implementation of key Strategic and Business Plans to meet Quality, Cost, and Delivery commitments. Develops annual budgets and establishes other key performance metrics/goals (in concert with AMO Global Operations and AMO Senior Leadership Team). Drives for needed results within the established Management review process to maximize the return on assets for AMO Milpitas. 6. Leads development and implementation of systems, policies, and procedures to assure compliance to all key areas (Quality, Procurement, Production, Distribution & Warehousing, Advanced Engineering, HR, and Finance). 7. In collaboration with Divisional and Corporate Quality Assurance, manages AMO Milpitas resources to effectively manufacture quality products per AMO Milpitas Quality System; which is fully compliant with GMP, ISO standards and EHS requirements. Ensures that Regulatory requirements are met. 8. In Collaboration with Divisional R&D; lead the Advanced Engineering efforts to improve DFx, Reliability, and Costs. Drive efforts to influence early design decisions that impact quality, reliability, and costs 9. Creates and maintains a work environment of participation, open communication, and recognition. Develops the appropriate organizational structure and skills to be successful in the achievement of strategies. Recruits, develops, coaches, and mentors senior leadership and management. Provides leadership and actively participates in the Global Manufacturing Team. Demonstrates global alignment by effective working relationships with peers. REQUIRED SKILLS: Minimum of a Bachelor’s degree in business, engineering, science, or manufacturing management or related technical field. Advanced degree in related field preferred. Minimum Experience: 8 – 10 years of management experience in a manufacturing environment. Minimum of 5 years personnel management and medical device management. Cross-functional management experiences in product development, engineering, manufacturing, quality, and OEM relationship management preferred. Demonstrated experience in spend analysis PPV, CPI, and cost reduction in a new product production environment desired. Experience with medical device product production preferred.

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******************************************************** https://jobs.smartbrief.com/action/listing?listingid=463F74FC-A105-459E-BCEC-3825DF9093F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Director of Global Infrastructure - 002196 Edwards Lifesciences Job Description Leadership: * Achieve excellence in defining, developing and deploying business-centric IT solutions * Champion change and effectively manage the implementation of new ideas * Provide leadership and management over the Irvine Infrastructure team * Provide leadership and support for regional IT resources * Promote the company through attendance and speaking engagements at industry conferences or involvement in local business organizations Departmental Management: * Define, develop, present to management, gain acceptance and approval of ITLT or CIO a plan that is aligned and coherent with an overall Global IT strategy plan * Lead global implementations, and provide technical oversight to regional IT projects to ensure they are in-line with global standards * Work with RMs, stakeholders and regional IT resources to assess and respond to day-to-day business IT needs * Hold regular departmental meetings to review strategic goals and initiatives, promote teambuilding and work to provide growth paths for staff * Supervise the ongoing operations of the Desk Top Support providing quality and timely support to Edwards employees concerning hardware and software needs * Lead recruiting, hiring, on-boarding and training for IT support staff * Administer the department budget * Defines and enforces standard company policies and procedures as it relates to Global Infrastructure * Serve on planning and policy-making committees as required Teamwork: * Reinforce team approach to problem resolution, especially as it pertains to working with the global IT team * Support and solicit input from team members at all levels within the organization Client Management: * Communicate effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, with always an eye toward a single, global solution * Continually define ways to increase internal client satisfaction and deepen client relationships * Provide senior level resolution to internal and external client issues Infrastructure and Desktop solutions (Hardware and Software): * Establish global infrastructure and application solution standards * Identify emerging information technologies to be assimilated, integrated, and introduced within the regional infrastructure fabric * Oversee the commissioning of infrastructure to ensure that it is harmonized with global standards, so that Edwards employees always have the same experience, “anywhere, anytime” * Oversee the testing, selection and implementation of new desktop solutions and changes to existing solutions that are (1) global in nature; and (2) localized just enough to meet the statutory and regulatory requirements in the region * Serve as primary contact with outside vendors in the generation of RFPs, bids, contracts, agreements, and other major vendor interactions Systems Operations and Maintenance: * Oversee the integrity and continual operation of the global network, including LAN/WAN and data center services * Ensure the continual functioning of mission critical infrastructure, application solutions and operations * Maintain security and privacy of the information systems, communication lines, and equipment * Define, develop, review, and certify all back-up and disaster recovery procedures and plans * Oversee IT related aspects of all the regional construction and renovation projects Education, Skills and Abilities: * B.S. degree in computer science, computer engineering, electrical engineering or related field, a Master’s degree is a plus * Ten years management/leadership experience, including deployment and management of global infrastructure an on a large scale * Experience moving or building a data center is highly preferred * Strong analytical and logical problem solving skills * Strong interpersonal communication and relational skills * Proven organizational and project management skills, working in a satellite location of a multi-national corporation, preferably US-based * User-centered attitude and willing to work in a team oriented environment that serves a diverse population * At ease in a matrix organization * Speaks English as a first language * Possess and displays sound judgment; initiative; flexibility and detail-orientation *******************************************************

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https://jobs.smartbrief.com/action/listing?listingid=16D1F2B2-AEF0-47FF-8038-58D1C97CB054&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Neurovascular Intervention Marketing Manager Asahi Intecc Job Description Asahi Intecc is a manufacturer of Disposable Medical Device that specializes in Coronary and Endovascular Products for the Interventional Market place. We are now hiring staff for Neurovascular Intervention Products. This position will be responsible for the marketing of Neurovascular intervention products. Responsibility includes - Product training to phycicians and lab staff - Promotion planning and implementation - Tradeshow planning and implementation - Clinical case observation and market feedback - Market analysis and marketing plan implementation - Clinical support for sales rep in the field - planning and preparation of marketing tools - Building a key opinion leader network ● Min 3yrs experience of Neurovascular Intervention Product Sales or marketing experience ● About 50% travel ***************************************************** Posted by Dave Catlin, Managing Director

To apply, submit resumes to jobs@genquestbio.com Clinical Trials Project Manager - SF Bay Area The selected candidate will oversee the conduct of all clinical studies performed and ensure studies are completed on time within budget and in compliance with SOP’s, FDA regulations and ICH/GCP guidelines. You will work as part of a cross-functional team to ensure completion of the project clinical goals and act as a primary interface with the CRO. You will manage communications between monitors, clinical sites and the CRO including the implementation and execution of clinical programs, development and administration of site and vendor budgets. You will coordinate with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals and resources. You will assist in the writing of protocols, the design of case report forms and other study documents as you work closely with external service vendors to oversee all aspects of the clinical trials. You will evaluate, tabulate and may prepare written summaries of clinical data. You will ensure compliance with protocol, overall clinical objectives and FDA/IHC requirements including conducting a review and source verification of clinical data to ensure timely resolution of data queries. Maintain contact with clinical investigators and staff and track all required site documentation. Qualifications include a BS/MS degree or equivalent in the life sciences, or a related technical degree with 8+ years of experience. Experience managing multi site trials, CRO’s and other vendors is required. You should also have experience in Clinical Trial Management, specifically

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demonstrating application of research methodology in a clinical trial setting. You should have thorough knowledge of GCP/ICH requirements and possess excellent oral and written communication skills. This position may supervise administrative support and other clinical staff and may be required to travel to clinical sites occasionally. This is a contract opportunity for approximately 6+ months in duration with the potential to convert to regular status. No relocation is offered for this position. ********************************************************* Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Project Coordinator Now hiring: Clinical Project Coordinator http://www.ziprecruiter.com/job/Clinical-Project-Coordinator/d6c54142/?source=social-linkedin-group-jobs ********************************************************* Qualified candidates please reply to: Cindy Johnson cjohnson@chozeninc.com tel: 925-577-8135 Below you will find an update on our most urgent openings in medical device in the San Francisco bay area. Most Urgent Positions: International Sales & Marketing Specialist Customer Service Specialist Product Manager SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT International Sales & Marketing Specialist

BA/BS degree International sales & marketing support experience (intl tradeshows, campaigns, etc) Experience designing & executing International Email Marketing, Mobile/SMS, Social

Media campaigns Foreign language skills strongly preferred (Spanish, Portuguese, Russian, Chinese or

Japanese would be ideal) Ability to travel up to 25% Medical device industry experience would be a plus (not required) Knowledge of Salesforce.com, MS Office, Access, Publisher and Project, Dreamweaver,

Fireworks, Flash, Freehand, Illustrator, Photoshop Customer Service Specialist

BA/BS degree 4+ years of customer service experience, medical device industry preferred Exceptional documentation skills, especially with order entry Attention to detail and accuracy are essential. Knowledge of Salesforce.com, MS Office, Access, Publisher and Project, Dreamweaver,

Fireworks, MAS 90 Proven ability to take initiative and learn in a smaller team environment strongly

preferred Product Manager

BA/BS degree Significant knowledge of interventional products, procedures and market trends 3+ years of Product Management experience within medical device industry Excellent written/oral communication skills Ability to travel up to 30% Startup experience would be a plus

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******************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=4870697&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3V9a9EIcbP65E1 Senior Program Manager--BEx Real Staffing Group- Santa Ana (Orange County, California Area) Job Description SR. PROGRAM MANAGER BEX The Sr. Program Manager BEX acts as a cross-functional change agent to build & reach consensus on identifying problem areas and pursuing recommended solutions to increase revenue growth, improve productivity and positively impact our customer experience. Develops and supports the senior leadership team in setting the vision for Business Excellence deployment, leads and mentors strategic complex process improvement projects following the Lean Six Sigma methodologies, and responsible for delivery of Business Excellence related training across the organization such as Lean Six Sigma Belt Training and Change Management Training. CORE JOB RESPONSIBILITIES: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. • Leads strategic, complex process improvement projects in the division. • Delivers strategic results in conjunction with division goals and objectives. • Evaluates business processes and determines initiatives that will yield greater productivity and efficiency to enable growth. • Acts as a cross-functional change agent to drive and sustain measurable BPI for the division. • Act as mentor, role model and coach in the implementation of BEx best practices. POSITION ACCOUNTABILITY / SCOPE: Develops and articulates a strategic vision for areas of responsibility. Leads assigned departments by developing, communicating and building consensus for goals and programs that support division, business unit and company objectives. Able to lead within a matrix organization. Creates mid- to long-range plans to carry out objectives established by top management; develops and calculates a budget for one or more departments to meet organizational goals; forecasts future departmental or group needs including human and material resources and capital expenditures; determines and establishes organizational structure and supervisory relationships subject to top management approval. Typically makes decisions that translate programs established by top management into operational plans and schedules; work is performed without appreciable direction; consequences of erroneous decisions or recommendations would normally result in failure to achieve goals critical to the major objectives of the organization and would seriously affect the financial, employment or public relations position of the company. Qualifications • 10+ years in management, 5+ years of direct management responsibility delivering significant strategic results for BPI initiatives. • Current Six Sigma Black Belt certification required; Six Sigma Master Black Belt certification is preferred but not required. • Proven ability to facilitate cross-functional change. • Demonstrated experience in deploying continuous improvement methodologies within a commercial organization (Sales and Marketing) desired. • Experience with direct Lean Six Sigma responsibility of delivering significant strategic results for continuous improvement initiatives preferred. • Strong project management skills & proficient with Lean Six Sigma tools and methods (DMAIC & DFSS) desired.

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• Excellent training and presentation skills with solid communication capabilities including oral and written desired. Education: Bachelor's Degree in business or a technical discipline. Company Description Real Staffing is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services and has one of the largest networks of specialist recruiters globally. Our premise is a simple one: by recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time. At Real Staffing we offer retained search as well as contingency recruitment within both the contract and permanent markets. Our consultants are market specialists and it is this in-depth market knowledge that allows our consultants to develop tailored recruitment solutions for this demanding recruitment market. We take the time to understand our candidates' current and future ambitions and actively seek out roles that will help take our candidates to the next level in their career. The strength of our client relationships and global network means we can access the best new roles within the sector. Whether you are looking to strengthen your team or looking for your next career move contact us today. www.realstaffing.com Additional Information Posted:February 13, 2013 Type:Full-time Experience:Not Applicable Functions:Project Management, Manufacturing, Business Development Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:$150K to $165K (depending on experience) Referral Bonus:generous bonus structure Job ID:4870697 *************************************************** http://jobs.celgene.com/go/sales-jobs/305809/?utm_source=Beaker&utm_campaign=Celgene_Tier1 Sales Jobs Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 75 countries that is helping to turn incurable cancers into chronic, manageable conditions. Our company’s deep and diverse pipeline of over 25 compounds in clinical development, which address more than 30 serious diseases, is a testimony to this commitment and has created accelerated growth opportunities across the organization. We are expanding our sales teams and seeking talented hematology and oncology sales professionals with a proven track record and the drive and initiative to sell in markets that revolve around complex science. Celgene has been consistently ranked as one of top sales forces in the industry, because of the knowledge and support the sales team demonstrate to improving the lives of the patients we serve. Celgene is an organization that not only recognizes performance, but also the manner in which performance is achieved. We offer an innovative workplace where diversity and cross-functional experiences are embraced, providing

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individuals an opportunity for continued personal growth and reward. We invite top performers who want to make a difference to consider the opportunity to join our Celgene Sales team. ___________________________________________________________________ http://jobs.celgene.com/go/research-scientist-jobs/305801/?utm_source=Beaker&utm_campaign=Celgene_Tier1 Research Scientist Jobs Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. What is it that defines Celgene? Most fundamentally, Celgene is its employees, who are focused on the mission of delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases. They are a varied group of talented people united in their commitment to discover, develop and market life-enhancing drugs that make a measurable difference in the lives of millions of people. Why Apply for Research Scientist Jobs with Celgene? If you would like to join the team and build on the Company's scientific and commercial achievements, apply for a Research Scientist job with Celgene today. Our goal is to attract the best people at every level of the organization, and you can help us achieve that goal! ****************************************************** https://jobs.smartbrief.com/action/listing?listingid=204F07A8-2717-45A8-9302-175B0507664F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/5/13 Location: Irvine, CA Years Experience: 3+ in related field Engineer, Process Development ArthroCare Corporation Job Description

Engineer, Process Development Irvine, CA

ArthroCare Corporation (Nasdaq:ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation(R) technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS(R) line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology.

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Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development. Summary: Design, Develop, Implement and Maintain Manufacturing Processes for assigned ArthroCare lines of products (devices). Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)

Responsible for developing and implementing new processes on new products and be the M.E. representative on development teams for designing, developing, implementing, and maintaining assembly, test, and packaging processes. Ensures that time lines, cost and quality expectations are met.

Develop new techniques for assembly and test, including test fixtures, with DOE and validating new processes, evaluate failure data from field to find root cause and implement sound engineering solutions.

Responsible for training techs and assemblers and supporting transfer of product into manufacturing facilities.

Provide accurate tracking and reporting on this activity. Provide continuous engineering support on assigned products to maintain and improve

margin, performance and quality. Work with R&D team leader to deliver acceptable documentation on product (including

but not limited to: Assembly and test fixtures, Routers, MPI, Test methods, Drawings and Specs) in a timely manner.

Participate and Manage (as required) engineering builds, verification and validation builds, and provide technical data/ report to the team leader.

Ensure compliance with ArthroCare quality system and all relevant internal procedures and policies (including but not limited to: ECN, NCR, CPR, BOM, Router, MPI/ SOP).

Work on cost reduction projects to reduce material/ process costs by defining and implementing new techniques and equipment/ fixtures for assembly and test. This may require designing fixtures and implementing in manufacturing facilities.

Assist and lead product and process transfers to Costa Rica manufacturing facility. Supervisory Responsibilities: Technicians and/ or clean room personnel as required Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Education and/or Experience:

Essential. B.S. or M.S. degree in Engineering. At least 3 years in related field. Prefer experience in medical and surgical devices, and implantable biomaterials.

Language Skills: Excellent communication skills, and problem solving skills. Ability to plan and schedule multiple projects and tasks. Fluent in Spanish a plus. Mathematical Skills: Needed for engineering position Reasoning Ability: Need to be able to make rapid and sound decisions Computer Skills: Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works. Certificates, Licenses, Registrations: None Other Skills and Abilities: Be able to work with people at all levels of organization and understanding of MRP and document control software. Other Qualifications: Assembly and test fixture designing skills. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.

For consideration of this position and other opportunities please visit our career center at:

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********************************************************* https://jobs.smartbrief.com/action/listing?listingid=463F74FC-A105-459E-BCEC-3825DF9093F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/8/13 Location: Irvine, CA Salary Range: Open Years Experience: 10 Director of Global Infrastructure - 002196 Edwards Lifesciences Job Description Leadership: * Achieve excellence in defining, developing and deploying business-centric IT solutions * Champion change and effectively manage the implementation of new ideas * Provide leadership and management over the Irvine Infrastructure team * Provide leadership and support for regional IT resources * Promote the company through attendance and speaking engagements at industry conferences or involvement in local business organizations Departmental Management: * Define, develop, present to management, gain acceptance and approval of ITLT or CIO a plan that is aligned and coherent with an overall Global IT strategy plan * Lead global implementations, and provide technical oversight to regional IT projects to ensure they are in-line with global standards * Work with RMs, stakeholders and regional IT resources to assess and respond to day-to-day business IT needs * Hold regular departmental meetings to review strategic goals and initiatives, promote teambuilding and work to provide growth paths for staff * Supervise the ongoing operations of the Desk Top Support providing quality and timely support to Edwards employees concerning hardware and software needs * Lead recruiting, hiring, on-boarding and training for IT support staff * Administer the department budget * Defines and enforces standard company policies and procedures as it relates to Global Infrastructure * Serve on planning and policy-making committees as required Teamwork: * Reinforce team approach to problem resolution, especially as it pertains to working with the global IT team * Support and solicit input from team members at all levels within the organization Client Management: * Communicate effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, with always an eye toward a single, global solution * Continually define ways to increase internal client satisfaction and deepen client relationships * Provide senior level resolution to internal and external client issues Infrastructure and Desktop solutions (Hardware and Software): * Establish global infrastructure and application solution standards * Identify emerging information technologies to be assimilated, integrated, and introduced within the regional infrastructure fabric * Oversee the commissioning of infrastructure to ensure that it is harmonized with global standards, so that Edwards employees always have the same experience, “anywhere, anytime” * Oversee the testing, selection and implementation of new desktop solutions and changes to existing solutions that are (1) global in nature; and (2) localized just enough to meet the statutory and regulatory requirements in the region * Serve as primary contact with outside vendors in the generation of RFPs, bids, contracts, agreements, and other major vendor interactions Systems Operations and Maintenance: * Oversee the integrity and continual operation of the global network, including LAN/WAN and data center services * Ensure the continual functioning of mission critical infrastructure, application solutions and operations * Maintain security and

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privacy of the information systems, communication lines, and equipment * Define, develop, review, and certify all back-up and disaster recovery procedures and plans * Oversee IT related aspects of all the regional construction and renovation projects Education, Skills and Abilities: * B.S. degree in computer science, computer engineering, electrical engineering or related field, a Master’s degree is a plus * Ten years management/leadership experience, including deployment and management of global infrastructure an on a large scale * Experience moving or building a data center is highly preferred * Strong analytical and logical problem solving skills * Strong interpersonal communication and relational skills * Proven organizational and project management skills, working in a satellite location of a multi-national corporation, preferably US-based * User-centered attitude and willing to work in a team oriented environment that serves a diverse population * At ease in a matrix organization * Speaks English as a first language * Possess and displays sound judgment; initiative; flexibility and detail-orientation ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=AB355F96-80F8-44D4-A925-7DA25F973B50&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/12/13 Location: San Jose, CA Salary Range: Open Years Experience: 8-10 DIR OPERATIONS, Milpitas Site - 130000007R Abbott Job Description The Director of Operations is responsible for managing the planning, development, implementation, and maintenance of the operations at the AMO Milpitas site. This includes overseeing production, manufacturing, processes, and operations for new and existing products through subordinate management personnel. Will direct the strategies and tactics of the site including matrix management of a broad multi-disciplined organization and providing direction and leadership. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Responsible for implementing and maintaining the effectiveness of the quality systems. 2. Directs the AMO Milpitas Site and Manufacturing Operations, and is responsible for all major Compliance systems (Quality, Procurement, Production, EHS, Scheduling, Costs) used in insuring the marketplace receives world-class products (Phacoemulsification Systems, Excimer Laser Systems, Femtosecond Laser Systems, Ophthalmic Diagnostic Systems) at a competitive cost and on-time. 3. Will lead Milpitas Site; but must work effectively with peer leaders in Global Operations and with other key functions within AMO (Quality, Regulatory, Legal, HR, R&D, Finance, Sales &

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Marketing) to obtain world-class results. 4. Will develop the strategic, capital, and business plans, including annual budgets for Operations to assure attainment of Standard Costs targets, Quality & Reliability targets, Capital targets, New Product Introduction targets, and Inventory targets. 5. Drives development and implementation of key Strategic and Business Plans to meet Quality, Cost, and Delivery commitments. Develops annual budgets and establishes other key performance metrics/goals (in concert with AMO Global Operations and AMO Senior Leadership Team). Drives for needed results within the established Management review process to maximize the return on assets for AMO Milpitas. 6. Leads development and implementation of systems, policies, and procedures to assure compliance to all key areas (Quality, Procurement, Production, Distribution & Warehousing, Advanced Engineering, HR, and Finance). 7. In collaboration with Divisional and Corporate Quality Assurance, manages AMO Milpitas resources to effectively manufacture quality products per AMO Milpitas Quality System; which is fully compliant with GMP, ISO standards and EHS requirements. Ensures that Regulatory requirements are met. 8. In Collaboration with Divisional R&D; lead the Advanced Engineering efforts to improve DFx, Reliability, and Costs. Drive efforts to influence early design decisions that impact quality, reliability, and costs 9. Creates and maintains a work environment of participation, open communication, and recognition. Develops the appropriate organizational structure and skills to be successful in the achievement of strategies. Recruits, develops, coaches, and mentors senior leadership and management. Provides leadership and actively participates in the Global Manufacturing Team. Demonstrates global alignment by effective working relationships with peers. REQUIRED SKILLS: Minimum of a Bachelor’s degree in business, engineering, science, or manufacturing management or related technical field. Advanced degree in related field preferred. Minimum Experience: 8 – 10 years of management experience in a manufacturing environment. Minimum of 5 years personnel management and medical device management. Cross-functional management experiences in product development, engineering, manufacturing, quality, and OEM relationship management preferred. Demonstrated experience in spend analysis PPV, CPI, and cost reduction in a new product production environment desired. Experience with medical device product production preferred. ***************************************************** Apply on company website Senior GxP Trainer Onyx Pharmaceuticals- San Francisco Bay Area Job Description Summary: This position is responsible for Onyx’s GxP training program. The individual in this position is

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responsible for conducting and providing GxP training to the Onyx team. Provides leadership in continuous system improvement of the GxP training program. They are also the administrator of the electronic Learning Management System (LMS) and ensure proper training of and course content for GxP personnel. This individual in this position provides leadership in continuous improvement according to GMPs/GLPs and current industry standards. They execute the training program for new and existing employees and are responsible for groups and individual training sessions, including scheduling, training material/media development, presentation and record keeping. Essential/Primary Duties, Functions and Responsibilities:

Responsible for the GxP training program. Develop GxP training content and materials (for electronic and in-person presentation

to the Onyx GxP community. Organize and present training sessions/classes to groups or individuals (on GxP

regulations/industry standards and GxP related Onyx procedures or policies). Assure that required departments are provided training on the regulatory requirements

and pertinent quality topics. Communicate compliance and quality policies on a company-wide basis. Ensure continuous improvement in the training program. Ensure Onyx departments and individuals comply with GxP training requirements. Responsible for tracking GxP training through the electronic Learning Management

System. Responsible for company adherence to GxP training program requirements. Provide GMP orientation for new hires. Administer training program documentation including managing training files, records

and database. Cross-train staff members on techniques for delivering compliance-training classes. Determine the GxP training needs for employees by working with department

management to align the GxP training curriculum with the specific job function. Develop and maintain the Onyx GxP Training website. Stay current in GxP regulations and industry standards that apply to Onyx. QA Support: Participate in FDA inspections, vendor audits and internal audits as

needed. Other duties as assigned.

Requirements Work Experience:

3+ years providing GxP classroom training. 5+ years in a QA, QC or Manufacturing position in the Biotech/Pharmaceutical/Device

industry. Familiarity with cGMPs/GDP and their application in a pharmaceutical or biologics

environment is essential. QA, QC or Manufacturing experience is required. Must possess working knowledge in database usage, and the ability to work

independently. Requires exceptional organizational and presentation skills, and the ability to effectively interact with diverse groups of people.

Functional/Technical Knowledge & Skills: Excellent oral and written skills. Strong leadership and public speaking skills Strong interpersonal skills, which include a professional demeanor when interacting with

personnel or regulatory authority representatives Knowledge of applications of instruction methodologies for the adult learner

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Sound and practical judgment in the interpretation and application of appropriate regulations

Able to communicate clearly with a variety of individuals in various departments Must be proficient in the following applications: MS Word, MS Excel, MS PowerPoint, and

MS Exchange/Outlook Ability to quickly learn and master new software applications

Customer & Industry Knowledge: Knowledge of GxP FDA regulatory requirements and industry standards. Knowledge of management and operation of a GxP training program for the

biotech/pharmaceutical industry. Education/Training:

Minimum of a BA/BS degree. Other Requirements:

Must have excellent customer-service orientation and ability to work with little or no direction.

Ability to communicate effectively in a learning and teaching environment. Must be flexible, able to manage multiple tasks, and have strong attention to detail. Ability to effectively communicate with internal and external contacts at all levels. Excellent organizational, written and verbal communication skills.

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:February 13, 2013 Type:Full-time Experience:Associate Functions:Science Industries:Biotechnology Job ID:4870998 ****************************************************** Apply on company website R&D Manager Bio-Rad Laboratories- Pleasanton, CA (San Francisco Bay Area) Job Description The R&D Manager, Digital Biology will be responsible for the invention and development of new reagent products for Bio-Rad’s Digital Biology Center. These reagents products will be used on the QX100 Droplet Digital PCR system, and future instrument systems that will expand Bio-Rad’s digital biology presence into additional fields and markets. This is a lead position that requires productive interactions with department leads and key collaborators to develop the product portfolio that meet the desired requirements. Responsibilities include being current with literature and interfacing with key collaborators to identify emerging technologies and the practical application of these technologies. Invent and establish concept feasibility of new products. Develop the physical product specifications and configurations that deliver the optimum product performance. Be a key member of the team that integrates these products with the associated emulsion chemistry and micro-fluidics. This person is expected to be a thought leader in digital biology emulsion chemistry, their applications, and gain a presence in the field through inventions, product commercialization, presentations and publications. These reagent products associated with digital biology systems

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include enzyme reaction mixes, detection chemistries, reaction additives, emulsion oils and emulsion surfactants. Desired Skills & Experience The R&D Manager, Digital Biology is responsible for new product development of chemistries used on the Bio-Rad digital biology platforms. Job duties include but are not limited to:

Identify emerging technology and practical product solutions through literature research and key collaborations.

Establish R&D plans, product portfolio and product specifications. Develop products according to the plan, with the delivery of physical product

specifications for manufacturing process development, as well as user protocols, and characterized workflow dependencies.

Evolve the development process to be able to launch into regulated markets as well as the research market.

Establish a presence and knowledge through presentations, posters and publications. Generate data that provides detailed performance information associated with the targeted applications.

Ensure all invention disclosure and patent applications are filed in a timely manner. Develop orthogonal analytical assays for product and component characterization. Productive execution of well thought out experiments, accurate recording of experiment

and results, in depth analysis and reporting of results. Company Description Bio-Rad, Inc. ranks among the top five life science companies worldwide, and maintains a solid reputation for quality and innovation. It develops, manufactures and markets a complete range of laboratory products used for research in molecular biology, biochemistry, microbiology, genetics, immunology, and chemistry. The group serves a growing base of customers in academic and biotechnology research, and in the pharmaceutical industry. Recently, the group introduced new products for use in the areas of DNA amplification, proteomics, and food testing, three fields in which Bio-Rad remains at the center of discovery. Bio-Rad is an Affirmative Action/Equal Opportunity Employer Additional Information Posted:February 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Research, Management Industries:Biotechnology Job ID:4872105 ****************************************************** Register on company website Started by Ron Bucher, Customer Support and Services Executive Service Logistics Manager position in Sunnyvale, CA Direct applicants only - no recruiters. Must have experience managing service logistics in medical industry. QAD experience highly advantageous. ****************************************************** Posted by Rebecca Janney, Clinical Research Recruiter - Permanent Placement Contact Rjanney@crnspg.com Biopharma in South Bay needs 2 CRAs - rjanney@crspg.com Clinical stage small biopharma is in need of 2 direct-hire, in-house CRAs. Will travel regionally 30-50%. Candidates must possess at least prior co-monitoring experience, all the way through senior level. Competitive compensation! Wear may hats!

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****************************************************** Apply on company website https://jobs.smartbrief.com/action/listing?listingid=63D9CFBA-AC3F-4E83-9C6E-6EBC28DAA413&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Counsel II, Legal (Anti-corruption) Gilead Sciences Job Description This position will report to the director of Gilead’s anti-corruption program within Commercial Legal. The individual will help implement an effective cross functional anti-corruption program at Gilead Sciences. The individual will help develop and carry out policies and procedures; provide business conduct and compliance support to Gilead’s emerging markets and international access operations (Gilead’s program to increase access to medicines and healthcare in low- and middle-income countries); assess and act upon issues identified during due diligence processes; assist in implementing training and communication plans; and contribute to monitoring, auditing and enforcement activities to ensure consistent application of Company policies. The individual will work in close coordination with colleagues in Legal, Business Conduct, Internal Audit, Finance, and other departments to complement existing compliance activities. ********************************************************** Contact If interested, contact: Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing T: 215-536-6979 F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com Medical Writer – San Francisco Position with pharmaceutical company is 3-month contract to possible perm. Responsibilities

1. Responsible for supporting CRAs and MDs in clinical protocol development, clinical study reports, Investigator's Brochures, informed consents and INDs/IMPDs. Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation.

2. Will also contribute to the development of medical writing infrastructure. Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas. Manages medical writing project timelines and manages all clinical writing activities outlined in the Project Clinical Development Plans. Reviews documents and offers guidance in the preparation of regulatory and publication documents.

3. Organizes, conducts, and leads document production meetings and other meetings as necessary.

4. Responsible for developing and managing, Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, IND sections. Proposes applications

5. Responsible for supporting the development of departmental infrastructure such as contributing to research, acquiring a document management system, establishing style

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guides, and generation of templates and processes. Skills

1. An ability to create effective presentations from raw data is essential. 2. An ability to interpret statistical and clinical data is essential. Must have an ability to

work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required.

3. Strong written and verbal communication skills are required. 4. An understanding of clinical research, biostatistics, and regulatory affairs is required. 5. Must have experience writing clinical protocols, clinical study reports, and IND sections.

Good computer skills are required. Working knowledge of MS word, Excel, Power point, Lotus notes is a plus.

Experience 1. A Bachelors/Masters degree in a scientific discipline with a strong journalism

background is required. 2. Equivalent experience may be accepted. 3. A minimum of 8 years in a pharmaceutical, biotech, or CRO medical writing position is

required. 4. A minimum of 6 years writing management experience is also required. 5. A minimum of 5 years previous supervisory experience is required.

*********************************************************************** Contact If interested, contact: Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing T: 215-536-6979 F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com Medical Writing Specialist – Pinebrook, NJ

Position is 11-month contract. Description

1. Uses project management skills to track, review and ensure timely completion of high quality documents.

2. Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.).

3. Independently compiles complete drafts of report appendices for clinical phase 1 /2a studies.

4. Act as a central resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintain departmental and project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines. Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.

5. Work with key interface partners to facilitate the completion of clinical study reports and their appendices. Ensure clinical documents adhere to global standards and are in accordance with electronic publishing Standards. Checks that study file components (eg, Investigator CV's, protocol and amendments, sample case report form) needed for the writing of CSRs are checked into the electronic archive (eg, eDMS) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (eg, heading styles, language, accuracy).

6. Proofreads, reformats and edits document text, as required, to ensure that all report appendices meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final

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QC, compilation and publishing. Reviews and performs QC checks of all documents and appendices to ensure consistency between and within documents.

7. Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.

8. Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary.

Minimum Requirements 1. Bachelor's degree or equivalent with at least 2-3 years of experience the

pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles.

2. The incumbent should have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (eg ICH, FDA, EMEA).

3. The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards.

4. The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.

5. The incumbent must be a skilled user of word processing applications. ************************************************************************* Contact If interested, contact: Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing T: 215-536-6979 F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com Medical Writer – Hopewell, NJ

Position is 6-month contract. Description

1. Bachelor's degree in relevant scientific discipline with a minimum of 3-5 years in pharmaceutical industry experience.

2. Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.

3. Good understanding of the global pharmaceutical drug development process and regulatory requirements for safety risk related documents. Additional knowledge of regulatory guidelines preferred (eg. Good Pharmacovigilance Practice and Good Clinical Practice Guidelines).

4. Demonstrated ability to perform detail-oriented review of complex data from a broad range of therapeutic areas and scientific disciplines. Have excellent attention to detail.

5. Demonstrated strong, effective organizational, facilitation, and interpersonal skills in communicating with cross-functional teams. Communicates with clarity and consistency while impacting alignment of stakeholder activities regarding safety risk related document reporting requirements. Successful and creative negotiation of difficult compliance issues. Strong ability to resolve and communicate quality issues, and perform root cause analysis.

6. Working knowledge of a document management system and basic knowledge of the document publishing process. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learnings.

Responsibilities

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1. Coordinate and verify the compliance of complex regulatory strategic safety risk related documents and submissions, with guidelines, local regulations, procedures and/or company requirements. Proactively gather information to improve training methodologies. Identify process improvement opportunities and champion their implementation, as assigned.

2. Perform detail-oriented review of complex safety risk related documents while leveraging several pieces of source documents (eg. meeting minutes, signal log, commitment database, SharePoint, document management system). Responsible for in process reviewing and QC/proof-reading of documents prepared by staff (for e.g. cross checking sections, data points, tables, regulatory templates). Prioritize to ensure that timelines are met. Participate in the development of quality-related processes and tools. Provide support for management of quality issues. Facilitate and advise on corrections, corrective and preventive actions related to designated quality issues. Identify trending and consistency of all safety risk related documents in the department. From trended data by maintaining quality tracking, offer process improvement innovation ideas.

3. Provide advice for maintaining and performing qualitative and quantitative review and checking safety risk related documents. Maintain a familiarity with company systems and related processes. Provide quality consultancy to other personnel.

4. Ensure compliance with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with the medical writer to ensure timely completion and high quality of assigned documents. Share information in an open, balanced and objective manner with other quality management and other professionals to positive, results-orientated team environment.

5. Report findings of quality control reviews clearly and within required timeframes. Review documents and provide documentation of requirements to the lead author. Attend (or where required, lead) internal quality focused meetings. Provides training and guidance to all functional area staff members on a variety of quality topics.

*************************************************************** Contact If interested, contact: Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482. Senior Manager, Medical Writing (Oncology) San Francisco Bay Area, CA

Position is permanent. Description

1. Demonstrated ability to prepare a wide range of regulatory documents, such as clinical study reports and Investigator Brochures, as well as CTD summaries, pediatric investigational plans (PIPs), and regulatory responses, in-line with regulatory requirements and internal document standards

2. Contributes to other non-regulatory medical writing activities as required 3. Participates in submission teams and provides advice/guidance for optimal presentation

of data for achievement of document objectives 4. Leads document timeline/resource planning for assigned projects within the submission

team 5. Works collaboratively with functional contributors (clinical, biometrics, virology etc),

ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines

6. Performance management may be required 7. Leads the compilation of final documents and appendices coordinating clinical,

biometrics and regulatory contributions

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8. Leads/contributes to development work in relation to document standards, continuing MS template development, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing

9. Provides scientific/regulatory writing services to support clinical trial reporting as well as a wide variety of regulatory submissions

10. Works with project teams across sites to produce complex clinical documents for global regulatory submissions

11. Is able to prepare a wide variety of regulatory documents independently or with minimal supervision

12. Writes multi-study summary documents for pivotal studies 13. Writes sections of product approval applications and other submissions 14. Works with Biometrics on clinical data interpretation 15. Reviews and prepares FDA briefing packages 16. Serves as a cross-functional resource.

Responsibilities 1. Requires a BS degree and 10+ years of relevant experience within clinical R&D or

regulatory affairs such as pharmaceuticals/biotechnology 2. Candidates with advanced degrees and less than 10 years of experience may be

considered 3. 5+ years experience in a medical writing/clinical submissions environment,

directing/preparing documents for regulatory submissions 4. Can facilitate issue resolution and lead multi-functional teams with clear direction

through complex processes 5. Demonstrated success in the independent preparation of regulatory documents,

particularly at the individual study report level 6. Strong knowledge of regulatory document requirements/guidelines

*************************************************************************** Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482. Regulatory Medical Writer (Oncology) San Francisco Bay Area, CA (East Bay)

Position is permanent. Description

1. Develop/write/edit documents for clinical development as well as technical/scientific publications

2. Will work closely with internal clinical development team members as well as external collaborators, such as KOLs and external vendors

3. Scope of documents range from pre IND through NDA 4. Provides broad medical writing and project management support for programs and

efforts of the Clinical Development group 5. Able to develop documents from scratch 6. Documents include but are not limited to briefing documents, clinical development

plans, previous human experience summaries, human pharmacology summaries, Investigator's Brochure, clinical protocols and protocol amendments, model informed consents, interim and final clinical study reports, INDs, patient narratives, and other documents that support Clinical Development

7. Authors/co-authors/edits publications (manuscripts, review articles, abstracts, poster and presentations, etc.)

8. Performs literature searches/reviews as necessary to obtain background information and training for document development

9. Work with document templates and support eCTD document submissions

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10. Facilitates review of materials/documents to enable timely finalization of documents 11. Builds agreement cross-functionally on timelines and document management to ensure

efficient document finalization 12. Assists with development and implementation of SOPs

Requirements 1. Bachelor degree REQUIRED, PhD preferred 2. Pharmaceutical clinical/regulatory writing experience a MUST

Contact **************************************************** Contact Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482. Regulatory Medical Writer (Infectious Disease) Boston, MA (Downtown)

Position is contract. Our client is looking for a medical writer who has experience writing protocols, Investigator Brochures, and Clinical Study Reports. Infectious Disease experience is required. The candidate must be on site at least 50% of the time. ******************************************************* Posted by Tamoy Kim, Recruiter at PROVEN, Inc. email Tamoy Kim at tkim@proveninc.com with your resume or referrals. Searching for Process Science Scientist, for Pharma in Irvine, CA Must have 5+ years of Downstream Process Development experience. Position will be leading group to design novel purification processes for monoclonal antibodies. Must have PhD. *************************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio.

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They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history)

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Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job.

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8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her

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LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************* Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings.

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The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf *************************************************************************

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Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************