Trainee (Implementation of WOM Quality Domain - set-up of ESECs on Biologicals and Chemicals)

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 Pharmaceutical Quality Office within the Human Medicines Division.

Specific objectives and projects

During your traineeship, you will take part in the set-up the European Specialised Expert Communities on Biologicals and Chemicals as part of the WOM Quality domain. The priorities are: a) to set-up processes to support the new ESECs to achieve optimal information sharing, b) knowledge management, c) training to the network NCA assessors, d) to develop a process to identify subject matter experts to join drafting groups. As part of the project you will do the following:

• familiarise themselves with the work of the BWP (Biologicals Working Party) and QWP (Quality Working Party) and the role of the ESEC to support both working parties and help deliver their workplans
• set-up lean processes to facilitate information sharing
• maintenance of knowledge and intelligence related to the Quality Domain work (including product assessment outcomes, policy decisions, etc.)
• support to ESEC communication pathways and modalities
• support to guidance activities and recruitment of experts from ESECs

Learning outcomes

Through this project you will have the opportunity:

• gain insight into the regulatory systems in the EU in the area of quality of medicines;
• gain insight into the functioning of the NCAs and the value that experts bring to EMA's work; 
• develop skills in communication, information management and change management;
• gain technical knowledge on the quality of medicines
• help become an ambassador in his/her future career of the EU regulatory network based on expertise, collaboration and worksharing

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 pharmaceutical sciences (e.g. pharmacy, biology, chemistry etc.)  (minimum of three years or more) that must have been obtained within the last 12 months (graduated between 20 May 2023 and 20 May 2024) 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

In addition to the eligibility criteria, you will have:

• Scientific and technical skills in the target area,
• analytical methods and research skills,
• Organisational skills,
• Communication skills (English writing and verbal)
• Advanced skills of Microsoft Powerpoint,
• Excel would be 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

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2024 – 31 July 2025) 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 €1,858.31 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.