Trainee: Focus on Sustainability of Network Operation (BWP/QWP) and Risk-Based Approaches (European Union Member State or Iceland, Lichtenstein and Norway Citizens Only)

Job Description

Selection procedure reference: EMA/TR/10913

Deadline for applications: 6 May 2025 23:59 CET

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

This traineeship opportunity is now open for applications until 6 May 2025 23:59 CET, with an intake on 1 October 2025.

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

The specific project aims at developing & implementing risk based approach to the Working Parties in the Quality domain (i.e. BWP and QWP) in order to optimise their support to the CHMP and make best available use of assessment resources in the network.

The trainee will get involved in tasks related to adapting the risk-based methodology to the operation of the Biologicals Working Party & Quality Working Party and support it’s roll-out.

The following steps are envisaged:

• developing a risk-based methodology adapted to the work of the Biologicals Working Party & Quality Working Party,
• roll-out to QWP/BWP and and rationalizing work practices of the two working parties (WPs) applying risk based principles,
• strengthening and aligning the way both WPs support CHMP in product evaluation,
• streamlining parallel activities and initiatives (new process for MAA/LE, new templates, workbook, revised clock stop rules).

Aspects of the project the trainee will look after:

• developing risk-based methodology,
• developing a training plan,
• organisation of training sessions,
• monitoring of outcomes of changes to be implemented,
• reporting to the Working Party/governance.

Learning outcomes

The trainee will gain an understanding:

• the importance of Pharmaceutical Quality and how Chemistry, Manufacturing and Controls (CMC) aspects are an important part of a medicines development and overall benefit/risk.
• knowledge of the Agency’s processes and procedures in the area of pharmaceutical quality and the EU regulatory network and will gain practical experience in the planning, preparation and strategic insight required to coordinate the work of the EU regulatory network.
• functioning of the EU regulatory system and the benefit of cross-EU collaboration between NCAs, pooling of expertise across NCAs.

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

• enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
• possess a university degree in pharmacy, chemistry, biology or an equivalent scientific discipline (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.
• 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

Exposure to or professional experience from an EU academic setting in pharmacy, chemistry, biology or an equivalent scientific discipline, preferably on topics related to innovation in pharmaceutical manufacturing approaches and contacts in academia are considered of benefit.

A higher degree would also be of benefit (e.g. masters, Ph.D).

Expected selection timelines

Deadline for applications: 6 May 2025 23:59 CET

Assessments (remote): From end of June 2025 to mid-July 2025

Decision and offers: By end of July 2025

Placement start: 1 October 2025

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.

Deadline for Applications: 6 May 2025 23:59 CET

“While we try our best to keep our information updated, the closing date of the actual job source may be changed by the recruiter without prior notice. With this, please make sure to check the official job link when submitting your application. Thank you.”