Trainee (Scientific Evidence Generation: Cooperation between regulators and HTA)

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 Scientific Evidence Generation Department within the Human Medicines Division.

Specific objectives and projects

During your traineeship, you will be involved in activities related to the EMA implementation of the Health Technology Assessment (HTA) Regulation. In particular you will be involved in the analysis of links between the work under the HTA Regulation and the New Pharma Legislation, with identification of resulting opportunities / gaps.

Furthermore, you will contribute to the ongoing HTA Regulation implementation work at EMA, such as process revisions as well as capturing experiences. You will also contribute to the technical work at the regulatory/HTA interface, by for example identifying topics for future regulatory/HTA technical collaboration.

Learning outcomes

Through this traineeship, you will

• Gain insights into the commonalities and differences between evidence requirements from regulators and HTA bodies.
• Contribute to the implementation of the cooperation between regulators and the new HTA structure under the HTA Regulation.
• Analyse opportunities for further strengthening collaboration under a revised Pharmaceutical Legislation.

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.