Director of Scientific and Medical Writing | Biologe (m/w/d)
BioNTech SE
Job Summary
This senior leadership position as Director of Scientific and Medical Writing involves ensuring the timely production of high-quality scientific and regulatory documents essential for developing novel therapeutic agents, spanning from early discovery through post-marketing approval. The role is highly hands-on, requiring the ability to manage complex writing tasks independently, including defining new procedures where standards are absent. Key responsibilities include writing, editing, and coordinating a wide range of documents, managing outsourced writing services, and ensuring compliance with international pharmaceutical regulations and good writing practices. Furthermore, the Director acts as a departmental Subject Matter Expert (SME) and a Line Manager, tasked with recruiting, supervising, mentoring, and developing a cohesive, innovative team. A critical component is leveraging extensive regulatory authority interaction experience to drive process optimization and define company strategies for all medical writing activities across the dual locations of Mainz and London.
Required Skills
Education
Not specified
Experience
- Independent execution of complex scientific/medical writing tasks without supervision
- Experience defining and adapting scientific documentation procedures
- Leadership experience in team creation, supervision, mentoring, and development of reports
- Extensive prior experience interacting with regulatory authorities
Languages
Additional
- Not specified
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