Trainee (Translational sciences: Implementing the '3Rs' in medicines development and regulation)

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 Translational Sciences Office within the Human Medicines Division.

Specific objectives and projects

During your traineeship, you will work on the project to implement the '3Rs' (replacement, reduction and refinement of animal testing) in medicines development and regulation: opportunities with the New Pharmaceutical Legislation.

You will contribute to the EMA preparedness for the new pharma legislation (NPL) as well as the increasing number of enquiries from Stakeholders and the media.

In particular, you will provide a quantitative and qualitative analysis of application (and opportunities for use) of 3Rs methods in Marketing Authorisation Applications and Scientific Advice requests, as mandated in the NPL. This will provide EMA with a baseline before the NPL, and it will help developing guidance for industry when it comes to implementing the NPL. 

You will also be involved in quantifying changes in animal testing over the past decade, to help respond to media enquiries and to measure the impact of 3Rs actions implemented following the 2010/63 legislation on the protection of animals used for scientific purposes.

During this traineeship project, you will also collaborate with EMA colleagues from the Veterinary Medicines Division.

Learning outcomes

Through this traineeship, you will

• gain insight into the regulatory systems for use of 3Rs in medicine development in the EU and globally;
• analyse which opportunities are being used and could be used better to replace, reduce, and refine animal testing for medicines; and
• help develop guidance for industry to implement such opportunities.

Eligibility criteria

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

1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2. possess a university degree in biomedical sciences (e.g. pharmacy or medicine) (minimum of three years or more) that must have been obtained between 30 September 2023 and 30 September 2024 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.
3. 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

In addition to the eligibility criteria, you will have:

• Organisational skills.
• Analytical methods and research skills.
• Advanced skills of Microsoft Powerpoint, Excel would be desirable

Behavioural Competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 March 2025 – 31 December 2025) 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 €1,858.31 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.