Infectious disease and/or vaccine Expert (m/f/d)

• Contribute and actively support scientific evaluation of emerging medicinal products including vaccines, diagnostics and therapeutics with regards to declared or potential public health threats.
• Contribute to Emergency Task Force (ETF) activities including scientific presentations, data and study protocols assessments and drafting minutes.
• Act as advisor to Rapporteurs and product team.
• Contribute to development of strategy and guidance with expert groups at European and Global level, including with European Institutions and Agencies, international regulators and scientific bodies.
• Contribute to developing and implementing strategy and analysis of medical countermeasures and epidemiology of emergent pathogens in conjunction with EMA, ECDC and international expert groups.
• Contribute to the objectives of the regulatory science strategy and EMA/EU network strategy in the area of competence.
• As appropriate, ensure that the objectives of the Council recommendations on vaccines are implemented including contribution to the EMA/ECDC platform on monitoring of vaccines B/R post-approval, especially on effectiveness studies.
• Related to product-specific development and licensing strategies, provide pro-active guidance on clinical and regulatory science aspects to internal and external stakeholders.
• Provide leadership and motivation to the product teams and technical contribution as required by the business processes in a matrix environment with respect to advice and evaluation of ant-infectives and vaccines.
• Foster quality of content through peer review (from pre-submission to post-decision) for scientific advice and marketing authorisation procedures.
• Responsible to lead the contribution to early scientific activities including literature review and interaction with developers.
• Perform horizon scanning activities for defining portfolios of medical countermeasures in the context of emerging health threats.
• Contribute to the scientific support of working parties in the area biological health threats and vaccines strategy, and scientific advisory groups; this includes acting as scientific secretary of such group if assigned.

To be eligible for consideration for this position, you are required to:

1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. possess a university degree in medicine, pharmacy, chemistry, biology, or an equivalent scientific discipline (minimum of four years or more) that must have been obtained by the closing date of this vacancy notice;
3. have at least 9 years of relevant professional experience after obtaining the relevant degree and before the closing date of this vacancy notice;
4. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
5. have fulfilled any obligations imposed by applicable laws concerning military service.

For criteria 1, 2 and 3, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.