Senior Medical Writer
Core
Deliver high-impact regulatory documents (Module 2-5, briefing books, safety updates) to support clinical development programs for antibody-based medicines.
Role type
Senior Medical Writer (Regulatory/Clinical)
Builds
Regulatory dossiers and clinical development documentation for biologic therapies
Domain
Biotechnology / Oncology / Immunology / Women's Health
Required skills
Medical writing, regulatory document preparation, ICH guidelines, GCP, clinical research, study designs, biostatistics, pharmacology, medical terminology, cross-functional collaboration, project management
Preferred skills
Experience with biologic therapies, AI-assisted writing tools, therapeutic area expertise
Technologies
AI-assisted writing tools
Responsibilities
Proactively preparing clinical and regulatory documents, organizing and conducting document review meetings, collaborating on content strategy, staying current on regulations, leading adoption of AI writing tools, building therapeutic area expertise
