Senior Scientific Specialist (GCP)

Type of position:
Temporary agent

Job Type:
22 November 2026 at 23:59 CET

Job grade: AD 8

Internal job grade and Interagency: AD06 and above

Type of position: Temporary agent

Selection procedure reference: EMA/AD/11637

Job title: Senior Scientific Specialist (GCP)

Talent Pool: AD08 Science & Regulation

Deadline for applications: 22 November 2026 at 23:59 CET

Salary: 9577,39 Euro(including local weighting) [1] plus benefits(see calculators on the right) (based on a fulltime contract (40hrs/week))

Location: Amsterdam, Netherlands (relocation to take up duties is mandatory)

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Role summary

Located in the Good Clinical Practice (GCP) area of the EMA Inspections’ Office, this role is at the forefront of contributing to EU compliance oversight, safeguarding clinical trial participants, and ensuring medicines are approved based on GCP-compliant studies, while supporting innovative trial approaches to bring new therapies to patients.

The role involves contributing to strategic initiatives such as GCP guideline development, technical advice related to the implementation of legislation, inspection coordination, supporting the GCP Inspectors’ Working Group (IWG), representing inspection topics internally and externally, and international collaboration.

We are seeking a motivated professional with strong GCP expertise, a broad understanding of the product lifecycle and how GCP inspections embed into the marketing authorisation process, and the ability to balance technical knowledge with strategic thinking. An ideal candidate will have strong communication and organisation skills, the ability to work autonomously but is also a good team player, and can drive topics forward, ensuring the views of stakeholders are heard, while also contributing their own expertise.

You will work alongside leading GCP and regulatory experts within the EMA Inspections Office, a team of over 30 compliance professionals across GxP disciplines. We offer a collaborative, professional, and forward-looking working environment.

In this role you will:

•    Contribute to/co-ordinate scientific and regulatory guideline development in the area of GCP, including providing scientific and regulatory input to the GCP Inspectors’ Working Group (IWG), supporting the building of consensus among members of guideline drafting groups, contributing to the implementation of new legislation and guidelines, whilst keeping overall objectives to protect patient and animal safety in mind.

•    Provide scientific specialist expertise, coordination and regulatory support to the review of GCP aspects for human and veterinary medicines across the life cycle of the medicinal product (e.g. scientific advice, evaluation of marketing authorisations and post-authorisation variations and line extensions).

•    Coordinate of EMA co-ordinated GCP inspections.

•    Coordinate and contribute to requests for technical advice on proposed new legislation.

•    Support collaboration with other regulatory working parties within the EU (e.g. with the CTCG), international co-operation on GCP related topics, including the exchange of compliance information with international partners, and promoting inspection reliance.

•    Present inspection topics at internal and external fora (e.g. to EMA management, to the GCP IWG, and at external conferences), acting as an ambassador for the Inspections Office.

Here is the link to the Role Description of Senior Scientific Specialist  outlining generic duties and responsibilities:

https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-senior-specialist-ad8_en.pdf

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:

1.    enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;

2.    have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);

3.    have fulfilled any obligations imposed by applicable laws concerning military service.

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Specific conditions:

1.    possess a university degree (minimum of four years) in  the field of Life Science (e.g. biology,biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.

or

2.   possess a university degree ( minimum of three years) in the field of Life Science (e.g. biology,biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.

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General Condition 1 and Specific Conditions 1 and 2 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Only eligible candidates will be assessed by the Selection Committee.

You will need to have:

Experience

• Out of the years of professional experience required above, at least 5 years of experience of relevance to clinical research/GCP. This experience could be gained from a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting and should have been obtained in the conduct, management, quality assurance/control (including audit/monitoring) or supervision (including inspection etc) of clinical trials.

Skills & Knowledge

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
• Presenting scientific, or regulatory matters at a high level (eg to experts);
• Proficient in the use of  modern IT systems, and has the ability to work with, analyse and draw conclusions from large sets of data;
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;
• Knowledge of the typical issues  and general methodology in clinical research.

Competencies you will need to have:

Role competencies

Influencing and persuading - Advanced

Prioritising and organising — Advanced

Scientific evidence management - Intermediate

Scientific product lifecycle and procedure management  - Intermediate

Sub-family competencies

Regulatory frameworks and strategy — Advanced

Applied knowledge — Advanced

Grade competencies

Adaptability and agility — Intermediate

Coping with pressures and setbacks — Advanced

Analysing and problem-solving — Advanced

Core competencies

Ethics and integrity — Intermediate

Team collaboration — Advanced

Customer centricity — Advanced

Results orientation — Advanced

Communication — Advanced

Cross-cultural sensitivity — Advanced

Continuous learning and self-development — Intermediate

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered Nice to have:

Education

• Masters in a relevant field of study (Medicine or Life sciences);

• Master’s degree in regulatory science and/or affairs, clinical research, risk-based quality management, or compliance oversight.

Experience

• Experience of working in pharmacovigilance operations or oversight.

• Non-clinical experience, in particular in the area of bioequivalence/bioanalytics;

• Clinical assessment at a National Competent Authority;

Selection procedure timelines - Please note, timelines may change

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Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.

Note:  Candidates who fail any assessment linked to any Need to Have requirement, Sub-family competencies, Role competencies, Grade specific competencies, and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria, Sub-family competences and Role competencies.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA - Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments) for an overview of the thresholds.

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Assessments

Next steps of selection may include preliminary assessments. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies ( pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process.

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tools used.

Reserve list and/or job offers

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.