Trainee (Strengthening EU Biotech Act Preparedness via Modernisation of the CTIS Training Catalogue)

This traineeship opportunity is open for applications until 06 May 2026 23:59 CET, with an intake on 1 October 2026.

Traineeship: Strengthening EU Biotech Act Preparedness via Modernisation of the CTIS Training Catalogue

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.

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 Clinical Trial Transformation Office.

Specific objectives and projects

This traineeship takes place in the context of the regulatory transformation of clinical trials in the European Economic Area. As the European Union and European Economic Area clinical trials environment continues to evolve and is shaped by the introduction of legislative changes in the context of the Biotech Act, the EMA will in sequence need to implement substantial changes in the Clinical Trials Information System. In this changing context, there is a growing need for clear, accessible and well-structured training materials to support a wide range of stakeholders.

The trainee will be involved in a high-impact project focused on the update, modernisation, and consolidation of the CTIS training catalogue, ensuring it is aligned with regulatory developments and prepared to support stakeholders in the context of the EU Biotech Act. Under the close guidance and supervision of experienced colleagues, the trainee will participate in a structured learning project designed to build familiarity with CTIS, regulatory training content, and collaborative working practices.

In this context, the trainee will:

• Become familiar with existing CTIS training materials by reviewing selected content to gain an understanding of structure, scope, and purpose, and to help identify potential gaps, overlaps, or content that may require updating
• Support exploratory work on the restructuring of the CTIS training catalogue, contributing observations and suggestions aimed at improving coherence, usability, and logical organisation, without responsibility for final decisions
• Assist with the updating of limited training content, under supervision, to reflect recent or upcoming regulatory and system changes, as a learning exercise in regulatory communication
• Contribute to drafting, editing, and formatting activities to develop skills in producing clear, accessible training materials for different user audiences
• Support interactions with subject‑matter experts by helping prepare materials for review, consolidating comments, and learning how technical accuracy is validated
• Help promote consistency of language, terminology, and structure across materials, as part of developing attention to detail and familiarity with institutional style
• Document observations, lessons learned, and suggested improvements, contributing input that may inform future training development, without responsibility for implementation

Learning outcomes

By the end of the traineeship, the trainee is expected to have developed:

• Solid understanding of the operations of the European Medicines Regulatory Network and its stakeholders
• Solid understanding of how clinical trials are regulated and supervised at European Union level
• Practical knowledge on the use and functioning of the Clinical Trials Information System (CTIS)
• Experience in reviewing, updating, and organising training and guidance materials
• Skills in translating complex regulatory and technical information into clear, user-friendly content
• Improved written communication skills in a professional, multilingual European environment
• Basic project coordination and change management skills, including planning tasks, tracking progress, and working with deadlines

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 pharmacy, medicine or biology (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. Specialisation in clinical trials desirable.
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

Good written and oral communication skills. Proficiency in AI, design and standard office software tools is 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

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.