Scientific Support Assistant

For the European Medicines Agency we are looking for a Scientific Support Assistant in the Office of Therapies for Neurological and Psychiatric Disorders!

Role summary

• Provide administrative and secretarial support to all procedures under responsibility of the Product Lead;
• Assist office staff with drafting, editing, formatting, tabling, distribution, filing and publication of documents (e.g. Opinion documents) and preparation of presentations and other documents for internal and/or external use;
• Managing the translations process of Opinion annexes;
• Preparing and updating of EPARs (European Public Assessment Reports);
• Records management of product related files;
• Responsible for the correctness of procedure related database entries.

Standard role duties & responsibilities:

• Contribute to the management and coordination of overall activities relating to pre- and post-authorisation activities;
• Provide accurate and timely administrative and organisational / logistic support in the preparation and follow-up of internal and / or external scientific, regulatory and procedural meetings;
• Prepare and ensure publication of relevant documents using pre-defined templates and formats where appropriate;
• Contribute to the management of files, statistics, data, databases, tracking lists, mailing lists and correspondence relating to the specific tasks assigned;
• Develop and update SOPs (Standard Operating Procedures), WINs (Work Instructions), user manuals, guidance documents and templates;
• Use administrative and procedural knowledge to identify potential difficulties, escalating issues to scientific staff and management as necessary;
• Contribute to the development and improvement of the processes.

A fulltime, temporary job from 3-03-2025 until 31-12-2025;

Salary range:

• 3716,24 gross per month (5 years of experience)
• 4204,68 gross per month (5 - 15 years of experience)
• 4757,31 gross per month (15 years of experience or more)

Interesting and challenging work that brings value to European citizens;

A diverse and stimulating working environment.

The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The agency is located in Amsterdam, Netherlands and employs over 900 people from across the EU. EMA's mission is to protect public health by ensuring that all medicines available in the EU are safe, effective, and of high quality.

Education:

• A level of post-secondary education attested by a diploma, or a level of secondary education attested by a diploma giving access to post-secondary education, and appropriate professional experience of at least three years;

Experience:

• Up to 6 years of full time relevant professional experience;
• In working in a regulatory environment characterised by processes and procedures, SOPs, WINs or other guidance documents;
• In database management and analysis and reporting;
• In stakeholder management;
• In working in public or regulatory sector.

Nice to have:

• Proof-reading skills;
• Knowledge and understating of commonly used IT tools and systems, such as SIAMED, EPPIT, EVVET, and meeting platforms;
• Knowledge of the EU regulatory framework;
• Knowledge of (business) process management.
• Excellent attention to detail
• Excellent organisational and time management skills
• Excellent communication skills
• Excellent team working skills;
• Strong ability to follow detailed processes and procedures;
• Tact and discretion in the handling of confidential files and information.

Got excited? Apply untill the 12th of March, 2025, by leaving your details on our website via the application button.