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European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

23 February 2017 EMA/662655/2015 Administration

Recruitment at the European Medicines Agency General information

Table of contents

1. Overview of the role and responsibilities of the European Medicines Agency ........................................................................................................ 3

2. Routes for authorisation of medicinal products in the European system . 4

3. Structure of the Agency ........................................................................... 5

4. Staff numbers, nationalities and age range ............................................. 5

5. Personnel policy ...................................................................................... 6

5.1. Recruitment of staff covered under the Staff Regulations (TA + CA) ........................... 6

5.1.1. Classification of posts ......................................................................................... 6

5.1.2. Education levels and professional experiences ....................................................... 7

5.1.3. Recruitment process for Temporary Agents and Contract Agents (short-term & long-

term) ........................................................................................................................ 9

5.1.4. Recruitment process for Contract Agents for temporary assignments ..................... 17

5.2. Recruitment of other positions not covered under the Staff Regulations .................... 18

5.2.1. Recruitment process for National Experts on Secondment ..................................... 18

5.2.2. Recruitment process for Trainees ....................................................................... 18

5.2.3. Recruitment process for Temporary workers through recruiting agencies ................ 18

Annex 1 Examples of job adverts ............................................................ 19

Specific objectives of the jobholder: ...................................................................... 19

Elements that will be taken into account in determining candidates to be invited for

test/interview: ...................................................................................................... 20

Experience and knowledge in the following areas would be an additional

advantage: ............................................................................................................. 20

Experience and knowledge in the following areas will form part of the written/oral

assessment: ........................................................................................................... 20

Essential requirements for admission to the selection procedure: ......................... 21

Specific objectives: ................................................................................................... 22

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Elements that will be taken into account in determining candidates to be invited for

test/interview: .......................................................................................................... 22

Elements that will be part of the oral assessment: ........................................................ 23

Essential requirements for admission to the selection procedure: .................................... 23

Annex 2 Examples of diplomas ............................................................... 24

Annex 3 Budget 2015 ............................................................................. 28

Adopted by the Management Board Dec 2015 .............................................................. 28

Annex 4 Agency staff ............................................................................... 29

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1. Overview of the role and responsibilities of the European Medicines Agency

Before a new medicine can be made available for use, it must undergo a complex and lengthy series of

toxicity, pharmacology and clinical tests. Public-health authorities must then evaluate the results of

these tests to verify that the medicine meets the necessary quality, safety and efficacy requirements

as set by legislation. Only then can the medicine be authorised for use. For veterinary medicines, there

is an additional requirement to establish safe limits for residues of the medicine in food produced from

a treated animal, to ensure that the food will not pose any health risk to the consumer. Legislation in

the European Union harmonises the test requirements between Member States, to ensure a

consistently high level of public-health protection throughout the EU.

The evaluation of test results for medicines is the primary purpose for which the European Medicines

Agency was created. It was established in 1993 by Council Regulation (EEC) No 2309/931, along with

new EU procedures for the evaluation and supervision of medicinal products for human and veterinary

use. London was chosen as the seat of the Agency by a decision of the Heads of State and

Government, and the Agency began its activities on 1 February 1995. For information on the legislative

environment in which the European Medicines Agency operates please see our website under the

following link. For detailed overview on the role of the European Medicines Agency in the European

regulatory system please see booklet The European regulatory system for medicines and the EMA.

This booklet is intended to explain how the European regulatory system for medicines operates. It

describes how medicines are authorised and monitored in the European Union (EU) and how the

European medicines regulatory network a partnership between the European Commission, the

medicines regulatory authorities in the EU Member States and the European Economic Area (EEA), and

the European Medicines Agency (EMA) works to ensure that patients in the EU have access to safe

and efficacious medicines.

The Agency operates at the centre of a European medicines network that comprises the national

regulatory authorities for human and veterinary medicines of all EU Member States and EEA-EFTA

countries2 alongside the EU institutions. Besides maintaining strong working ties with these key

partners, the Agency nurtures relations with the stakeholders on whose behalf it operates, namely

patients, healthcare professionals and pharmaceutical companies. At the international level, the

Agency collaborates with a number of non-EU regulatory authorities on issues of common interest, and

is an active contributor to international forums in the global regulatory arena.

Working with all of these partners and stakeholders, the Agency seeks to apply the best-available

scientific know-how to the task of regulating medicines in Europe, for the benefit of public and animal

health.

Among its principal activities, the Agency:

provides independent, science-based recommendations on the quality, safety and efficacy of

medicines, and on more general issues relevant to public and animal health;

applies efficient and transparent procedures to help bring new medicines to the market by means of

a single, EU-wide marketing authorisation (the centralised procedure);

implements proactive measures for supervising the quality, safety and efficacy of medicines to

ensure that their benefits outweigh their risks;

1 Council Regulation (EEC) No 2309/93 of 22 July 1993, Official Journal L 214 of 24 August 1993. 2 These are Iceland, Liechtenstein and Norway, which are members of both the European Economic Area (EEA) and the European Free Trade Association (EFTA).

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000127.jsp&mid=WC0b01ac0580029320http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2014/08/WC500171674.pdf

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provides scientific advice and access to incentives to stimulate the development and improve the

availability of innovative new medicines, including medicines for rare diseases;

establishes safe limits for residues of veterinary medicines used in food-producing animals;

involves representatives of patients, healthcare professionals and other stakeholders in its work, to

ensure their needs and concerns are taken into account;

publishes impartial and comprehensible information about medicines and their optimal use;

develops best practice for medicines regulation in Europe, and contributes to the harmonisation of

regulatory standards at the international level.

Detailed information about each of these core tasks, mission statement, and about all the other

activities of the Agency, is available on the Agency website.

2. Routes for authorisation of medicinal products in the European system

The centralised procedure is compulsory for:

human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases,