Trainee (Optimising assessments in the context of referral procedures)

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 Quality and Safety of Medicines Department.

Specific objectives and projects

Referral procedures on human medicines can encompass both nationally authorised products and centrally authorised products as well as marketing authorisation applications. These procedures require EMA to carry out a scientific assessment of the issue 'referred' to it, in relation to a particular medicinal products or class of medicines, or scientific matter, so that it can make a recommendation for a harmonised position across the EU. 

Some referral procedures may affect hundreds of medicinal products, and assessors often need to review extremely large numbers of data submissions from different MAHs/applicants in sometimes very short timeframes.

In this context, the selected trainee will be involved in a project aiming at optimising and facilitating assessment of all data gathered by committees and assessors with a view to creating greater capacity and capability within the EU regulatory and scientific network. Ultimately, this will contribute to better support robust outcomes to better protect public health.

The trainee will be expected, with support from relevant colleagues, to: 

• Review recent procedures and identify possible areas for improvement.
• Review existing guidance for assessors (e.g. templates, training materials) and contribute to developing innovative proposals to streamline and optimise referral assessment.

To achieve these goals, coordinate and facilitate meetings, ensuring communication and collaboration between key stakeholders, including rapporteurs from scientific committees, assessors, and any relevant internal/external stakeholders, as needed.

• Support the preparation of any revised guidance/training material for assessors

Learning outcomes

The trainee will:

- gain knowledge of the functioning of the Agency, its scientific committees and the EU regulatory network; 
- gain a good understanding of the different types of referral procedures;
- strengthen their knowledge of the EU pharmaceutical legislation;
- develop and enhance skills in data analytics, project management, organisation and communication. 
 

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 life sciences (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

• Excellent communication skills with ability to compile, summarise and present information clearly and effectively, Proficient in English (verbal and in writing)
• Good analytical and organisational skills
• Good project management skills and knowledge of different IT systems
• Proactive and collaborative approach

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 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.