SNE/Clinical Data Publication Manager

About this position:

European Medicines Agency is looking for a Data Publication Manager responsible for assessing the commercially confidential information (CCI) and the anonymisation proposed by the marketing authorisation holders/applicants in the context of Policy 0070 - Clinical data publication and other transparency measures as necessary.

In this job you will:

• Provide support, advice and guidance to marketing authorisation holders in preparing packages for clinical data publication.
• Assess the Commercially Confidential Information (CCI) and anonymisation proposed by marketing authorisation holders/applicant in the context of clinical data publication.
• Liaise with outside agencies e.g Health Canada and EC on similar clinical publications.
• Present for peer review assessments of MAH’s/Applicant’s proposed redactions and anonymisation within set deadlines defined by the CDP process.
• Support with checking documents to be published in EPARS and risk management plans.
• Identify issues and escalate them to the Head of service.
• Prepare and/or develop internal and external procedural guidance documents and provide training as required.
• Answer assigned requests for information (RFIs) in line with the Agency’s practice.
   

Apply if you meet these eligibility criteria:

• Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine;
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• Currently  employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State, the European Free Trade Area (EFTA), candidate countries and public intergovernmental organisations (IGOs).

You will also Need to Have:

Education:

• A level of education which corresponds to completed university studies of at least three years attested by a diploma;

  Field of study

  Medicine, pharmacy or other life sciences, or related area.

Experience:

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study;
• At least 3 years of professional experience in the field of law, medicine, pharmacy, clinical research, pharmaceuticals, biotechnology, regulatory affairs, life sciences, scientific or related area.

Skills and knowledge:

• Knowledge of regulatory affairs, marketing authorisations, transparency activities.

These are Nice to Have:

Experience:

• In regulatory affairs of medicinal products and/or medical, pharmaceutical, or life sciences field and/or law;
• In working as part of a multinational team.

Skills and knowledge:

• Knowledge of the anonymisation of personal data;
• Knowledge of the clinical development of medicinal products.