Scientific Specialist (GCP)

• Contribute to/coordinate scientific and regulatory guideline development in the area of Good Clinical Practice (GCP).
• Provide scientific and regulatory input to the GCP Inspectors’ Working Group (IWG).
• Support the building of consensus among members of guideline drafting groups.
• Contribute to the implementation of new legislation and guidelines, whilst keeping overall objectives to protect patient and animal safety in mind.
• Provide scientific specialist expertise, coordination and regulatory support to the review of GCP aspects for human and veterinary medicines across the life cycle of the medicinal product (e.g. scientific advice, evaluation of marketing authorisations and post-authorisation variations and line extensions).
• Coordinate EMA coordinated GCP inspections.
• Coordinate and contribute to requests for technical advice on proposed new legislation.
• Support collaboration with other regulatory working parties within the EU and international cooperation on GCP related topics, including the exchange of compliance information with international partners, and promoting inspection reliance.
• Present inspection topics at internal and external fora (e.g. to the organization's management, to the GCP IWG, and at external conferences).

What they ask

• Strong GCP expertise.
• Broad understanding of the product lifecycle and how GCP inspections embed into the marketing authorisation process.
• Ability to balance technical knowledge with strategic thinking.
• Strong communication and organisation skills.
• Ability to work autonomously but also a good team player.
• Ability to drive topics forward, ensuring the views of stakeholders are heard, while also contributing own expertise.

• University degree (minimum of four years) in the field of Life Science (e.g. biology, biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) obtained by the closing date of this vacancy notice, and at least 9 years’ relevant professional experience after obtaining the relevant degree.
• OR university degree (minimum of three years) in the field of Life Science (e.g. biology, biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) obtained by the closing date of this vacancy notice, and at least 10 years’ relevant professional experience after obtaining the relevant degree.
• At least 5 years of experience of relevance to clinical research/GCP, gained from a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting.
• Experience obtained in the conduct, management, quality assurance/control or supervision of clinical trials.
• Thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2).
• Critical review and drafting of scientific and regulatory documents for expert and lay audiences.
• Presenting scientific, or regulatory matters at a high level.
• Proficient in the use of modern IT systems, and has the ability to work with, analyse and draw conclusions from large sets of data.
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU.
• Knowledge of the typical issues and general methodology in clinical research.

Desired.

• Masters in a relevant field of study (Medicine or Life sciences).
• Master’s degree in regulatory science and/or affairs, clinical research, risk-based quality management, or compliance oversight.
• Experience of working in pharmacovigilance operations or oversight.
• Non-clinical experience, in particular in the area of bioequivalence/bioanalytics.
• Clinical assessment at a National Competent Authority.