Medical Writer, Regulatory (Contract)

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. Title: Medical Writer, Regulatory (Contract) Reports to: Sr. Director, Medical Writing Location: Remote (West coast hours preferred) Duration: Through December 2026 with potential extension based on business needs Hours: Approximately 20 hours per week, with flexibility needed based on project demands Hourly rate: $170-$190/hr Summary Kyverna is seeking an experienced Contract Medical Writer to provide regulatory medical writing support for development programs. This individual will serve as an independent contributor responsible for developing high-quality regulatory documents supporting FDA interactions and clinical development activities. The ideal candidate brings extensive medical writing experience in Autoimmune diseases (Stiff Person Syndrome, Myasthenia Gravis, Progressive Multiple Sclerosis) and has a proven ability to independently author complex regulatory documents with minimal oversight. This role will partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional stakeholders to support critical regulatory milestones. 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