Principal Medical Writer

Key responsibilities:

• Formulate writing strategy for key clinical and regulatory documents and regulatory submissions; guide medical writing document preparation
• Assume lead role for the preparation of key clinical and regulatory documents and documents supporting regulatory submissions as well as responses to regulatory agencies/health authorities
• Lead writing strategy providing expertise including organization, content, and timelines
• Provide input and work with cross-functional teams for study designs, Protocols, CSRs, sections of INDs, NDAs, and MAAs
• Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content and adherence to regulatory requirements
• Lead document submissions and meetings
• Provide cross-functional guidance for document preparation, including US and EU regulatory guidance and requirements
• The principal medical writer is seen as an expert in medical writing and performs work independently with minimal supervision

Education and skills:

• Advanced degree
• At least 7 years of experience writing clinical/regulatory documents for pharmaceutical, CRO, or biotechnology company required
• Experience as the lead writer for key documents including FDA and international regulatory submissions required
• A clear understanding of clinical development, including phases, processes, and techniques used within a clinical development area from protocol design through regulatory submission
• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (CTDs)