European Medicines Agency
Trainee (Data analysis to improve Marketing Authorisation Application Validation process & guidance)
Job Description
Selection procedure reference: EMA/TR/10477
Deadline for applications: 20 May 2024 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.
The 2024 Traineeship programme is now open for applications until 20 May 2024 23:59 CET, with an intake on 1 October 2024.
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 Procedures Office within the Human Medicines Division.
Specific objectives and projects
During this traineeship, you will perform an analysis of the most common deficiencies identified during the validation of initial Marketing Authorisation Applications (MAAs) to identify particular areas of concern and trends. An analysis of the questions based on the category of stakeholder (Big Pharma company, SME, Academia) and type of product (chemical, vaccine, Advance Therapy Medicinal Products [ATMP]…) can also be performed to assess if there are significant differences and identify the need for more focussed communication. With this information you will support the simplification of the validation checks and propose updates to the current internal and external guidance to address the most frequent questions, improve transparency and reduce the number of deficiencies. It can also be used to inform the concept papers on the new validation process to identify immature applications as part of the new Pharma legislation.
You will also support the improvement of the internal knowledge sharing and staff training by adapting current internal documents, suggesting and implementing improvements on training materials and organizing the information for easy access.
Learning outcomes
Through this project, you will:
- gain insight in the validation of initial MAA
- develop skills in data analysis, communication and change management
- gain insight into training needs for procedures office staff, and the development of a training toolkit.
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, medicine 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.
- 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:
- Good analytical methods and organisational skills
- Good writing communication skills with ability to compile, summarise and present information clearly and effectively
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
Deadline for applications
20 May 2024 23:59 CET
Assessments (remote)
From beginning of June 2024 to beginning of July 2024
Decision and offers
By end of July 2024
Placement start
1 October 2024
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.
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Domenico Scarlattilaan 6 – 1083 HS Amsterdam – The Netherlands
Telephone +31 (0)88 781 6000 – Email [email protected]
© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.
