Traineeship: Regulatory Science Considerations and Conclusions in Assessments of New Medicines (European Union Member State or Iceland, Lichtenstein and Norway Citizens Only)

Job Description

Selection procedure reference: EMA/TR/10936

Deadline for applications: 6 May 2025 23:59 CET

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

This traineeship opportunity is now open for applications until 6 May 2025 23:59 CET, with an intake on 1 October 2025.

About the traineeship programme: The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master’s students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description: We are looking for a trainee in the Regulatory Science and Innovation Task Force.

Specific objectives and projects: As the selected trainee you will be involved in a project to do explorative research on aspects of how medicines are being evaluated. The research and development of medicines entails a variety of methods and evaluations that are used by developers. The regulator’s assessment of applications for marketing authorization of medicines covers also these evaluation methods (e.g., a slightly modified definition of an endpoint, a variation of an assay). The question is, how have changed or new evaluation methods been assessed and considerations been expressed independently from the medicine?

You will be involved in:

• Review public assessments reports by CHMP and possibly other regulatory medicines regulatory agencies
• Identify product-independent considerations and conclusions, describe their regulatory science impact, enrich findings with confidential data
• Design an approach based on 2. to be carried out systematically for a defined set of medicines
• Compose presentations, recommendations and a report, and if possible contribute to a scientific publication

Learning outcomes

• Improved understanding of the latest scientific advances in medicine development and technologies supporting development
• Gaining experience in critically reviewing scientific information and data, as well as in writing scientific reports
• Understanding of the EU and its medicine-regulatory system
• Improved understanding of medicine development

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

• enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
• possess a Master degree in medicine, life sciences, statistics, drug regulatory affairs or applied philosophy and ethics, that must have been obtained between 6 May 2024 and 6 May 2025 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master’s student with a previous fully finished degree in the areas mentioned before.
• a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages

For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.

Additional skills

• Programmatic data analysis including of text corpora;
• Critical thinking;
• Writing synthetic reports.

Expected selection timelines

Assessments (remote): From end of June 2025 to mid-July 2025

Decision and offers: By end of July 2025

Placement start: 1 October 2025

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €1,942.19 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.

Deadline for applications: 6 May 2025 23:59 CET

“While we try our best to keep our information updated, the closing date of the actual job source may be changed by the recruiter without prior notice. With this, please make sure to check the official job link when submitting your application. Thank you.”