Medical Writer, Regulatory
New
K
Kyverna TherapeuticsBiopharmaceutical
Remote within the United States, West coast hours preferredContractSenior
Salary170 - 190 USD per hour
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Job Details
- Experience
- 10+ years
- Required Skills
- Project ManagementGCP
Requirements
- 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.
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.
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