About this position:

The European Medicines Agency (EMA) is seeking a motivated Seconded National Expert (SNE) to join the H-TA department and contribute to an evolving area of vaccine science. As research into the potential impact of vaccination on non-communicable diseases (NCDs) expands, interest in scientific advice and in seeking NCD indications for vaccines is growing. This role offers an exciting opportunity to work at the forefront of scientific and regulatory developments, bringing your expertise in vaccinology, immunology and inflammation to the evaluation of vaccines for NCDs.

In this role, you will contribute to the assessment of applications for vaccines seeking an NCD indication in the EU, advise the Agency and its scientific committees, and help shape policy development, including scientific guidelines. Your specialist knowledge will support scientific assessment and the development of regulatory approaches in this emerging field.

In this role you will:

Act as an expert in vaccinology, immunology and inflammation; performing the following tasks:

• Provide specialised input with respect to the role of chronic inflammation as a common underlying factor in multiple NCDs, alongside disease-specific pathophysiological pathways; characterise the role of the immune system and how immune-mediated interventions, including vaccination, may support disease prevention.
• Provide continuous scientific support and knowledge transfer to experts and colleagues relevant to the impact of vaccination on NCDs through regular trainings and contribution and/or preparation of relevant meetings.
• Participate in regulatory science projects (such as guidelines for the assessment of applications for prevention or treatment of NCDs by vaccines) in collaboration with scientific committees with the aim of providing the best scientific support in the therapeutic area as well as efficient and effective regulatory practices.
• Provide scientific support during evaluation and critical peer review of applications from scientific perspective.
• Ensure high quality of relevant documents to be published for procedures following Commission Decision as well as contributing to the preparation of other communication documents (e.g. Lines to Take, Press Release, Question & Answer, scientific publications) as appropriate.
• Help establish appropriate investigational frameworks for the pre- and post-licensure evaluation of NCD vaccines.
• Promote and drive continuous improvement in the assessment of applications for vaccines seeking a NCD indication.

Apply if you meet these eligibility criteria:

1. Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine; 
2. Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the EU (at least level B2); 
3. Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional /local public administration) in an EU Member State and are due to remain in such employment for the foreseen duration of the SNE position.

Essential requirements

Education

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

Field of Study

• Medicine or Life Science (e.g. biology, chemistry, biochemistry, pharmacy).

Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study; 

• Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human medicines

Skills & Knowledge

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences;

• Presenting scientific, or regulatory matters at a high level (including experts);

• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;

• Knowledge of the typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;

• Knowledge of general methodology for quality, non-clinical, or clinical development;

• Knowledge of at least one area relevant for quality, non-clinical, or clinical development of medicines.

These are considered as nice to have:

Experience

• Experience in working with stakeholders (industry and national/international authorities)