Associate Director, Scientific/Medical Writing | Pharmacist (m/w/d)
BioNTech SE
Job Summary
The Associate Director, Scientific/Medical Writing, based in Mainz, Germany, is responsible for the timely generation of high-quality scientific and regulatory documents crucial for the development of novel therapeutic agents, spanning from discovery through to marketing approval. Day-to-day tasks involve hands-on writing, editing, and formatting a wide range of complex documents (such as CTPs, CSRs, IBs, and CTD modules) largely according to standard procedures, while also adapting and defining new procedures as needed. The role requires coordinating document preparation, review, and approval processes, ensuring compliance with international pharmaceutical requirements (e.g., ICH guidelines), and managing outsourced medical writing services. Key qualifications include an advanced science/medical degree (MD, Pharm.D, or Ph.D.), over five years of hands-on experience in drug development and scientific/medical writing within the pharmaceutical/biotech industry. This position demands excellent attention to detail, advanced software proficiency, and the ability to interpret and summarize complex scientific results clearly.
Required Skills
Education
Relevant science/medical university degree (M.D., Pharm. D, or Ph.D.)
Experience
- >5 years (hands-on) experience working in drug development in a therapeutically relevant field (preferably oncology and/or immunology)
- >5 years (hands-on) experience as a scientific or medical writer in the pharmaceutical/biotech industry
- Prior experience drafting documents for multiple indications
- Prior experience drafting new or updated CTPs and CSRs required for Phase I-III trials
- Prior experience drafting low to medium complexity variants of IBs, clinical CTD modules, DSURs/Annual Reports, RMPs, and other CTD Module 1 documents
- Prior experience editing/reviewing R&D reports
Languages
Additional
- Background knowledge in immunology and oncology (ideal)
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