Associate Director/Director, Medical & Regulatory Writing

Role: Senior Medical Writing Director specializing in clinical regulatory documentation for oncology therapeutics at a biopharma stage company. Responsibilities: lead authoring and management of clinical study reports, protocols, amendments, Investigator Brochures, and briefing books; provide guidance on document strategies for regulatory submissions such as INDs and NDAs; oversee vendor relationships and develop operational process improvements in medical writing. Collaboration with cross-functional teams including clinical research, data management, biostatistics, and regulatory affairs is essential to ensure high-quality, timely submissions adhering to ICH-E3, GxP, and FDA/ICH guidelines. Requirements: Bachelor’s, Master’s or PhD in a relevant scientific or medical field; 10-12 years of industry experience as a medical writer, with oncology experience preferred; proven expertise in clinical document authoring, regulatory submission processes, and project management; strong knowledge of regulatory standards, literature citation tools, and document formatting software. High-Value: Oncology, clinical phase documentation, regulatory submissions (IND/NDA/BLA), vendor management, GxP and ICH compliance, experience with electronic document management systems (e.g., Veeva, Documentum). Location: not specified, but extensive industry experience suggests significant cross-functional and regulatory interaction.