- 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.
Project ManagementGCP