Clinical Data Publication Assistant

For the European Medicines Agency we are looking for a Clinical Data Publication (CDP) assistant in the Office of Clinical Data Publication !

EMA proactively publishes clinical data submitted in support of marketing authorisation applications. You will be responsible for the process management of CDP procedures as per the assigned portfolio and interacting with stakeholders, as appropriate, as well as providing support to other Agency transparency measures as required.

Duties & responsibilities:

• Accountable for transparency procedures and the process of management of Clinical Data Publication procedures as per the assigned portfolio according EMA processes and in line with Policy 0070 on the proactive publication of clinical data;
• Responsible for entering data accurately in the relevant workflow tool and tracking table and for the provision of data for reporting purposes;
• Ensure that all steps of the process are handled in a timely manner and according to policy criteria;
• Responsible for publishing updates on the relevant intranet pages;
• Support the management of the EMA publication tool including delivering training within the team, answering queries from users and liaising with IT and the software provider;
• Responsible for the preparation of the expected list of documents for publication, and subsequent validation of packages received;
• Liaise with the document specialist regarding the assessment of the proposed and final packages of documents received for publication on the CDP Portal;
• Ensure documents have been correctly redacted/anonymised according to the agreed methodology in the anonymisation report;
• Support publication of the Final Redacted Document Package;
• Accountable for the correct filing in the EMA document management system;
• Answer Requests for Information (RFI) in line with the relevant SOP;
• Responsible for entering data accurately in the relevant workflow tool (extracted from SIAMED or IRIS systems).

A fulltime, temporary job from 3-03-2025 until 28-02-2026;

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 document management.
• Understanding of the regulatory framework that applies to the work of the Documents Access and publication Department;
• Understanding of the policy (policy 0070) that applies to the work of the Clinical Data Publication team;
• Knowledge of core administrative activities (e.g. records management, meeting management).

Got excited? Apply untill the 7th of February, 2025, by leaving your details on our website via the application button