Director, Scientific/Medical Writing | Pharmacist (m/w/d)

Job Summary

This Director, Scientific/Medical Writing role in Mainz, Germany, requires an expert to lead the timely generation of high-quality scientific and regulatory documents for novel therapeutic agents, spanning from discovery through marketing approval (BLA/MAA). The successful candidate will operate with significant autonomy, handling low to high complexity writing tasks, and leading the preparation of clinical sections of regulatory dossiers. Key responsibilities include hands-on writing, editing, and formatting a wide range of documents, coordinating the review and approval process, and ensuring strict compliance with international pharmaceutical regulations and good writing practices. This position demands extensive prior strategic experience in medical writing for regulatory submissions, a strong background in drug development (preferably oncology/immunology), and the ability to act as a departmental subject matter expert, driving process optimization and managing external writers effectively. A relevant advanced life science degree (M.D., Pharm. D, or Ph.D.) is essential for this senior leadership role.