Senior Medical Writing Lead – Regulatory Docs (Remote)

Kyverna Therapeutics, Inc.; Northern (KY); Hybrid; USD 170,000 - 190,000; Full time

Benefits offered by this job

Bonus eligible

Stock plan participation

Benefits

Job summary

Kyverna Therapeutics, Inc. is seeking a Senior Manager, Medical Writer to provide regulatory medical writing support for development programs, including FDA interactions and RMAT/Breakthrough Therapy planning.

The role emphasizes independent authorship of complex regulatory documents and collaboration across Clinical Development, Regulatory Affairs, and cross-functional teams. The ideal candidate has 10+ years in medical writing within biotech/pharma, advanced life sciences training, and strong

Qualifications

• Advanced degree in Life Sciences or related field preferred.
• 10+ years of medical writing experience in biotech/pharma.
• Extensive experience independently authoring FDA regulatory documents.
• Proven experience developing FDA briefing documents (RMAT, Breakthrough Therapy).
• Strong experience drafting clinical protocols and synopses.
• Thorough understanding of FDA regulations, ICH guidelines, and GCP.
• Ability to manage multiple projects with minimal supervision.
• Exceptional scientific writing, editing, and communication skills.
• Experience in fast-paced cross-functional clinical development environments.

Responsibilities

• Independently author, edit, and finalize complex regulatory documents for development programs.
• Lead development of FDA briefing documents for RMAT, Breakthrough Therapy, and other regulatory interactions.
• Develop clinical protocol synopses and support full protocol development for studies.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other teams to synthesize information.
• Drive document timelines, coordinate reviews, and deliver high-quality documents on schedule.
• Ensure alignment with FDA guidance, ICH guidelines, and company standards.
• Participate in document planning meetings and provide input on structure and messaging.
• Support additional regulatory and clinical documents as needed.

Skills

Regulatory writing

Cross-functional collaboration

Project management

Scientific communication

Clinical development familiarity

Education

PhD / PharmD / MD or equivalent

Job description

Kyverna Therapeutics, Inc. is seeking a Senior Manager, Medical Writer to provide regulatory medical writing support for development programs, including FDA interactions and RMAT/Breakthrough Therapy planning.

The role emphasizes independent authorship of complex regulatory documents and collaboration across Clinical Development, Regulatory Affairs, and cross-functional teams. The ideal candidate has 10+ years in medical writing within biotech/pharma, advanced life sciences training, and strong