Clinical Data Publication Assistant at the European Medicines Agency Amsterdam • Driessen

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Help make clinical research transparent and accessible across Europe! Are you detail-oriented and ready to contribute to public health on a European scale? Join the European Medicines Agency in Amsterdam!

What will you do?

As a Clinical Data Publication Assistant, you will support the proactive publication of clinical data submitted for marketing authorisation applications. As EMA relaunches this process, you will coordinate the Clinical Data Publication (CDP) procedures within your assigned portfolio, handle process management, and interact with various stakeholders. You will also support broader transparency efforts across the Agency.

Your responsibilities include:

• Managing CDP procedures and ensuring alignment with EMA Policy 0070
• Accurate data entry into workflow tools and reporting databases
• Timely handling of each step in the publication process
• Publishing updates on relevant intranet pages
• Supporting the EMA publication tool and responding to user queries
• Preparing expected document lists and validating document packages
• Liaising with document specialists on final document reviews
• Verifying proper redaction and anonymisation
• Assisting in the publication of Final Redacted Document Packages
• Ensuring accurate filing in the EMA document management system
• Handling Requests for Information (RFIs) in line with internal procedures

Who are you?

You are a detail-oriented and proactive team player with administrative experience and a strong sense of responsibility. You enjoy working in a structured and international environment, and you're motivated to contribute to public health transparency.

You bring:

• Post-secondary education proven by diploma, or secondary education with access to post-secondary education plus at least 3 years of relevant experience
• Up to 6 years of full-time relevant professional experience
• Experience in document or records management
• Understanding of EMA’s regulatory framework and Policy 0070
• Knowledge of administrative processes such as records and meeting management
• A structured way of working with strong attention to detail
• Excellent communication skills, both written and spoken
• The ability to handle legal timelines and procedural requirements

Where will you work?

You will be working at the European Medicines Agency (EMA) in Amsterdam, an EU agency responsible for the scientific evaluation and supervision of medicines in the EU. EMA offers a multicultural, international, and collegial working environment located at the heart of the Zuidas business district.

What do we offer?

• A competitive salary, equal to function group FGIII, starting at €3.759,07 and up to a maximum of €5.159,00 gross per month, depending on your qualifications;
• Opportunity to work in the multicultural environment of an EU Agency at the Zuidas in Amsterdam;
• You will be granted vacation days and receive 8.33% vacation pay on your earned salary;
• Pension from your first working day via STIPP;
• Assistance at the end of an assignment or employment to help you find a new job;
• We also offer free participation in various training courses and workshops.

• Ons team met adviseurs staat altijd voor je klaar, ook bij vragen over plezier in je werk, mantelzorg of je financiële situatie.
• Gratis opleidingen en workshops zowel online als op locatie door de beste trainers.
• Betaal minder belasting met onze reiskosten-uitruilregeling.
• Korting op je (zorg)verzekeringen en sportabonnement.

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