Trainee (Change management linked to the use of clinical study data in medicine evaluation)

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 Data Analytics and Methods Task Force.

Specific objectives and projects

During the traineeship, the trainee will work on projects to support the transformation of the European Medicines Regulatory Network (EMRN) to a more data-driven regulatory network. The trainee will be involved in the development and implementation of change management activities (eg., trainings, communication, review of guidance and requirements...) on the use of clinical study data (individual patient data in electronic strucutured format) to support medicine evaluation.

This will include strengthening of the support to EMRN in terms of implementing the use of clinical study data in the regulatory assessment and regularly liaising with a wide range of stakeholders including different EMA functions, national competent authorities, members of the Agency's scientific Committees and Working Parties members, but also international regulatory agencies.

Learning outcomes

The learning outcomes will be

1. Understanding of how the access and use of clinical study data can support medicine evaluation
2. Development and application of effective change management strategies in a complex regulatory environment
3. Understanding the operations of the European Medicines Regulatory Network and its stakeholders, including other international regulatory agencies (e.g. US FDA, Japan PMDA)
4. Working in an interdisciplinary project team, contributing to its objectives through individual tasks and collaboration
5. Working in a stimulating and international environment
 

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 business, change management, communication and policy linked to innovations (minimum of three years or more) 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.
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

• A university degree in biostatistics/epidemiology, data science or medicine/pharmacy could also match if the candidate has also good communication skills.
• Experience in international environments and networks, communication
• Knowledge of Agile methodology

Behavioural Competencies

You will demonstrate the following behavioural competencies:

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

Expected selection timelines

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.