SNE/Scientific Specialist (science & regulation)

About this position

The Regulatory science and Academia Workstream unit is looking for a seconded national expert for 2 years to work with the team on the following tasks:

• Contribute to the purpose of the Regulatory science and Academia Workstream, which is to coordinate the collaboration with academia to accelerate the translation of academia-originating solutions into medicinal products, drug development tools and regulatory science progress;
• Working as EMA’s Academia liaison with scientists from the regulatory network, researchers and developers from the academic sector, not-for-profit organisations, research consortia and networks; 
• Strengthening the EMA’s partnerships with academia in the EMA framework of collaboration, and dynamizing the EMA Academia matrix, delivering on its Action plan, working with the Academia group of the EU-Innovation network. 

In this role you will

• Coordinate the EMA Academia matrix and develop the matrix further as a dynamic community of staff from across the EMA engaged with academia. Lead the delivery of its action plan, creating joint deliverables that increase the value interactions with academia and of Agency initiatives directed at academia;
• Identify and address strategic gaps in interactions and support of academia concerning medicines, technologies and methodologies, by profiling the landscape of relevant academic research and development and by learning from Agency-wide interactions; 
• Drive the further development and application of EMA’s framework for collaboration with academia, continually engaging EMA colleagues, including:
• Coordinate interactions with researchers and developers from the academic sector on their plans and solutions, facilitate understanding their challenges, discuss strategic scientific (e.g., research design) and translational aspects (e.g., valorisation activities), provide conceptual support through briefing meetings, and engage them on the Agency’s needs to address regulatory science challenges; 
• Provide coordination support to EMA initiatives directed at academia, not-for-profit organisations and non-commercial sponsors (e.g. in the areas of advanced therapies, repurposing and large multi-national clinical trials), in collaboration with the relevant EMA workstreams and offices; 
• Identify scientific disciplines and research topics for developing EMA expertise and liaison with academic groups, recruit researchers into the Stakeholder database, including for engaging their expertise where needed in the EMA;
• Identify and promote best practices and methodologies on collaborative initiatives between academia and regulatory authorities; 
• In collaboration with the Stakeholders and Communication Division and the EU Network Training Centre, contribute to develop and execute an education and communication strategy with outreach and engagement of academic stakeholders (e.g., creating academia-targeted materials, webinars, online tutorials, events, lectures, information for website and social media).

• Participate in the review of requests for regulatory services by academia, such as validation, handling incentives, evaluating public health impact and scientific questions;  
• Contribute to identify, analyse and synthesise emerging regulatory science issues and drug development tools, to inform EMA regulatory science recommendations and actions; exploring opportunities for pre-competitive research collaboration to address the issues; develop partnerships with academia and not-for-profit research organisations, engaging research funders and regulatory network scientists; 
• Contribute to the EMA’s preparations for changes to the legislative framework;  
• Support the EMA’s exchange programmes and placements to promote learning between academia and the Agency (Seconded national experts, Collaborating experts, Visiting experts); 
• Contribute to the activities of the Workstream and Taskforce to deliver on the Regulatory Science Strategy 2025.

Apply if you meet these eligibility criteria

• Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway; 
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional / local public administration) in a European Union (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
Life Science (e.g. medicine, 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;
• Demonstrated expertise of at least 3 years in a life science research relevant to human or veterinary health;
• Demonstrated experience of at least 5 years in project management (can include clinical trials) and conducting critical appraisals in the biomedical field (e.g. grant application evaluation, article peer review, project evaluation, technology transfer). 

Skills & Knowledge

• Have a thorough knowledge of the landscape of actors and activities in the translational life cycle from researchers to patients; 
• Have a thorough knowledge of English language including in writing scientific reports; 
• Organisational skills;
• Communication skills;
• 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);
• Proficient in English language;
• Proficient in MS Office suite;
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU.

Nice to have

Education

• PhD in Medicine or Life sciences.

Field of study

• Scientific background relevant to perform the role.

Experience

• In programmatic data collection and analysis;
• Work in technology transfer; 
• Clinical experience in a therapeutic field;
• Non-clinical experience;
• Pharmaceutical development experience;
• Medicines assessment at a National Competent Authority;
• Experience in working with stakeholder organisations.

Skills & Knowledge

• Knowledge of typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;
• Knowledge of methodology for quality, non-clinical, or clinical development;
• Knowledge of at least one area relevant for quality, non-clinical, or clinical development of medicines.