Trainee (Change management linked to the use of RWE in medicine regulation)

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 Real World Evidence Office within the Data Analytics and Methods Task Force.

Specific objectives and projects

During your traineeship, you will be involved on projects to inform the transformation of the European Medicines Regulatory Network (EMRN) to a more data-driven regulation network in the area of Real-World Evidence (RWE).

This will imply (amongst other tasks):

• participation in the establishment of a process to strengthen scientific committee support in terms of RWE and regular liaison with a wide range of stakeholders from EMA staffs and members of the EMRN (European Medicines Regulatory Network) more specifically, support the establishment of regular alignment circles with relevant Human Medicines Division functions and, building on the existing processes for signals and PSURs, develop proposals for additional collaboration mechanisms and processes to identify/anticipate RWE research needs.
• reviewing the experience with a new training capability which is under deployment, called the Real-World Academy and based on lessons learned, inform the continuation of the program in 2025 (collection of possible topics, building a process for a yearly plan for the trainings, contact with the trainers to discuss objectives, content...).
• based on an existing stakeholder analysis, review current communication efforts for any gaps and contribution to enhancing communication 1) on the RWE generation by the team at EMA and the network in the bi-monthly newsletters, 2) on the content of the annual report (which will be released in June-July).

Learning outcomes

In this traineeship, your learning objectives will be:

1. Understanding of how the generation and use of RWE can support medicines regulation,
2. Development and application of effective change management strategies,
3. Understanding the operations of the EU medicines network. 

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 and policy linked to innovations background or biostatistics/epidemiology, data science or medicine/pharmacy (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 some experience in international environments and networks, communication.

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.