Regulatory Medical Writer

Job Summary

Seeking a part-time contract Regulatory Medical Writer, the individual will independently author and finalize complex regulatory documents supporting FDA interactions and clinical development activities while working remotely with flexible hours based on project demands.

Key responsibilities

• Independently author, edit, and finalize complex regulatory documents ensuring scientific accuracy and compliance with regulatory requirements
• Lead the development of FDA briefing documents and contribute to clinical protocol synopses and full protocol development
• Collaborate with cross-functional teams to gather and synthesize scientific and clinical information while managing document development timelines

Required qualifications

• Advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related scientific discipline preferred
• 10+ years of medical writing experience within the biotechnology or pharmaceutical industry
• Extensive experience independently authoring FDA regulatory documents, including briefing packages and clinical development documents
• Proven experience developing FDA briefing documents supporting RMAT and Breakthrough Therapy Designation
• Thorough understanding of FDA regulations, ICH guidelines, and GCP requirements