Trainee (Change management linked to streamlining clinical trials under the EU Biotech Act)

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

Traineeship opportunity: Trainee (Change management linked to streamlining clinical trials under the EU Biotech Act)

We are looking for a trainee in the Clinical Trial Transformation Office.

Specific objectives and projects

During the traineeship, the trainee will work on projects to support the transformation of Europe into a global biotech powerhouse. These changes will require structured change management efforts to ensure organisational readiness, clarity of workflows, and smooth transition for internal and external stakeholders. This traineeship project is designed as a learning‑oriented support initiative, allowing the trainee to gain practical exposure to regulatory change management within a complex public organisation, while contributing in a limited and supervised manner to ongoing preparatory activities.

Within a structured learning framework, the trainee will:

• Learn about upcoming regulatory and organisational changes by supporting background research and reviewing high‑level documentation related to the EU Biotech Act, CTIS, and ACT EU, in order to understand how legislative initiatives translate into organisational change.
• Develop change‑management skills by assisting with the collection, organisation, and summarisation of information for readiness or impact assessments, as a learning exercise in identifying operational implications and stakeholder needs.
• Gain exposure to change management tools and approaches by contributing, under guidance, to the preparation of draft or illustrative materials (e.g. engagement outlines, training concepts, or transition overviews), without responsibility for final content or decisions.
• Build familiarity with regulatory guidance and internal requirements by supporting reviews of selected guidance, training materials, or procedural documents to identify areas that may require clarification or adaptation, as part of a supervised analytical exercise.
• Develop collaborative working skills by supporting interactions with colleagues and subject‑matter experts, including preparing materials for discussion, consolidating feedback, and observing how technical and policy input is integrated.
• Strengthen drafting and analytical skills by documenting observations, summarising findings, and capturing lessons learned related to organisational change processes, for internal reflection and learning purposes.

Learning outcomes

1. Understanding the European Medicines Regulatory Network’s efforts and legislative framework around innovation and streamlining of clinical trials
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
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 or policy linked to innovations (minimum of three years or more) that must have been obtained between 6 May 2025 and 6 May 2026 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 university degree in clinical trials, medicine/pharmacy could also match if the candidate has also good communication skills).
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

Additional skills

In addition to the eligibility criteria, you will have:

• Experience in international environments and networks;
• Communication skills;
• 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
• Learning and development

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2026 – 31 July 2027) 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 €2,049.77 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.

What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)