SNE/Scientific Specialist (Inspections Office)

Type of position: Seconded National Expert

We are looking for National Experts on Secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years and may be renewed once or more, up to a total of four years.

EMA is offering an opportunity for a Seconded National Expert (SNE) to join the Inspections Office in the manufacturing stream.

The position is to support a range of core activities across the Inspections Office, adjustable depending on the needs of the office, including:

• GMP inspection co-ordination with EU NCAs for centrally authorised product inspections
• GMP product support for pre-approval and post-approval centrally authorised products
• Coordinating quality defects, falsifications, non-compliance statements and rapid alerts for centrally and nationally authorised products, as required
• Supporting work of the GMDP IWG, including involvement in and leading drafting groups, and supporting the use of digital technologies in inspections
• International cooperation in relation to inspection planning and sharing of compliance information, including Mutual Recognition Agreements

The position is offered for an initial period of two years with a possibility for extension. You will join a team of senior specialists.

In this job you will

• Provide scientific coordination and regulatory and/or procedural support in relation to the development, evaluation and surveillance of medicinal products for human or veterinary use
• Apply EU pharmaceutical legislation to the operations of the Agency as required
• Lead the development of regulatory and/or procedural guidance documents and provide training as required
• Contribute to and support discussions at the Inspectors’ Working Groups, and lead drafting groups/subgroups
• Respond to requests for information received by the EMA in the scientific field

In particular, the scientific specialist will:

• Liaise with internal and external stakeholders, interested parties, and subject experts
• Coordinate, support and lead effective communication and relations
• Manage daily internal communication and interaction related to procedures with colleagues across the Agency and the extended product team members

Eligibility criteria

• Enjoy full rights as a citizen of an EU Member State, Iceland, Liechtenstein, 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
• Be currently employed in the public sector, such as a university, research institute, public hospital or regulatory body, in a European Union Member State, the European Free Trade Area, candidate countries or public intergovernmental organisations

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 in Life Science, such as Pharmacy, Medicine and/or other Biomedical Sciences

Experience

• At least 3 years of experience, from the time when the university degree was awarded, as a GMP inspector

Skills & Knowledge

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences
• Ability to manage projects and obtain buy-in from stakeholders, with a focus on efficient and outcome-driven practices
• Knowledge of inspectorate Quality Management Systems
• Ability to present scientific or regulatory matters at a high level, including to experts
• Knowledge and understanding of EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU

Nice to have

Education

• Master’s degree in a relevant field of study, such as Medicine or Life Sciences

Experience

• Scientific background relevant to perform the role
• Experience conducting or being subject to audits under the Joint Audit Programme

Skills & Knowledge

• Project management

What we offer

• Meaningful work contributing to protecting the health of every individual and animal in Europe within a multinational, multidisciplinary team
• Development opportunities, such as internal mobility, mentoring, peer coaching and career reflection programmes
• Work-life balance through flexible working arrangements, teleworking, generous annual leave and official holidays