Job Description

Responsibilities

Independently author, edit, and finalize complex regulatory documents supporting clinical development programs, ensuring scientific accuracy, consistency, and compliance with regulatory requirements.
Lead development of FDA briefing documents, including materials supporting RMAT, Breakthrough Therapy Designation, and other Agency interactions.
Develop clinical protocol synopses and contribute to full protocol development for clinical studies.
Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other functional teams to gather, interpret, and synthesize scientific and clinical information.
Drive document development timelines, proactively managing reviews, incorporating cross-functional feedback, and delivering high-quality documents on schedule.
Ensure documents are aligned with FDA guidance, ICH guidelines, and company standards.
Participate in document planning meetings and provide strategic input on document structure, messaging, and regulatory presentation.
Support additional regulatory and clinical documents as business needs evolve.

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, meeting requests, and clinical development documents.
• Proven experience developing FDA briefing documents supporting RMAT, Breakthrough Therapy Designation, or similar regulatory interactions.
• Strong experience writing clinical protocols and protocol synopses.
• Thorough understanding of FDA regulations, ICH guidelines, and GCP requirements.
• Ability to independently manage multiple projects with minimal supervision while meeting aggressive timelines.
• Exceptional scientific writing, editing, communication, and project management skills.
• Experience working in fast-paced, cross-functional clinical development environments.

Contract Details

Anticipated engagement through December 2026, with the possibility of extension based on project needs and regulatory timelines.
Average commitment of approximately 20 hours per week.
Workload will fluctuate throughout the engagement, with periods requiring near full-time availability during active document development and regulatory submissions, followed by lighter workloads during review cycles and Agency response periods.
Remote within the United States.