Scientific Support Assistant (Procedure Office)

For the European Medicines Agency we are looking for a Scientific Support Assistant in Procedure Office!

The candidate will be responsible for the support and end-to-end management of regulatory procedures under the responsibility of the Procedures office related to the marketing authorisation of centrally authorised medicinal products in the EU. These procedures are minor variations to marketing authorisations, minor procedures, pre-submission activities, notifications for parallel distribution, certificates for medicinal products.

The role implies validation of submitted information, management of procedures according to SOPs, interaction with internal and external stakeholders (e.g. scientific assessors of EU member states, pharmaceutical companies), preparation and publication of documents, record keeping and maintenance and update of information in our databases.

• 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:

• Administrative experience working in an office environment is needed. High attention to detail, accuracy and ability to multitask and comply with tight deadlines are also needed. Previous experience working on a pharmaceutical company/regulatory authority is desirable.
• 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.

Skills & Knowledge:

• Administrative skills;
• Knowledge and understating of commonly used IT tools, applications and systems, including MS Office, teleworking tools and meeting platforms.

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