Trainee (Medicines for children - status of authorisation of medicines for children in the EU)

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 Paediatric Medicines Office within the Human Medicines Division.

Specific objectives and projects

As a trainee in the Paediatric Medicines Office (PME) you will be involved in a project for the analysis of authorised paediatric indications to enhance transparency and public awareness of such developments and support New Pharma Legislation (NPL) discussions.

Currently an IT tool is being developed to reliably track paediatric indications granted in the past as well as on an ongoing basis in the future. Previously, an analysis of the paediatric indications granted has been performed for the 10 year report to the European Commission in 2017. These data need updating, as also requested by stakeholders, on an ongoing basis to communicate EMA's work related to paediatrics as special population. For the NPL these data will serve as baseline and support NPL discussions on (unmet) public health needs. Furthermore they are needed for optimisation of international collaboration and comparison with other regulators (e.g. USFDA -US Food and Drug Administration- publishing these data on a quarterly basis).

Within this project you will:

• familiarize themselves with the Paediatric Regulation, the work of the PME/ Paediatric Medicines Committee (PDCO) as well as relevant aspects around MAA and variations;
• define with the mentor the data to be gathered;
• complete the data collection since 2017;
• set up a common and easily searchable database (e.g. by type of product, therapeutic area, condition, indication, formulations) integrating the data of all paediatric indications granted since the Paediatric Regulation came into force;
• do a qualitative and quantitative analysis of all paediatric indications granted according to therapeutic area, condition, indication, formulation etc including a gap analysis. This should be then published as a peer-reviewed paper.

Learning outcomes

Through this project, you will have the opportunity to:

• gain insight into the regulatory system to support development of medicines in underserved areas as well as principles of authorising medicines in the EU;
• understand the achievements and challenges of medicine development in children in the EU and international context;
• contribute to strengthening the evidence base for discussions on unmet medical needs in paediatric patients;
• use and gain experience in designing, conducting, analysing and communicating a regulatory-scientific project including preparing presentations and a publication.

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, medicines or life sciences (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:

• Organisational skills.
• Communication skills (English writing and verbal).
• Analytical methods and research skills.
• 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.