Medical Writing Operations Manager

Kyverna Therapeutics • Emeryville, CA

2d • $125,000 - $140,000 • Hybrid

About The Position

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.

The Medical Writing Operations Manager will drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions. This role is responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment. The ideal candidate is detail-oriented, proactive, and highly organized, with demonstrated experience navigating regulated documentation and submission environments.

Requirements

• 7+ years in medical or regulatory writing operations within a GxP environment
• Hands-on SOP authorship and routing experience, ideally with DOT or similar systems
• Strong coordination and document control experience across review cycles, including experience with Veeva or similar regulatory document management systems
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines
• Strong interpersonal and communication skills, with proven ability to build trust across cross-functional teams
• Exposure to regulatory submissions (INDs, BLAs, CTDs)
• Well-versed in inspection-readiness documentation practices

Nice To Haves

• Experience coordinating CSR appendices and other cross-functional components of BLA submissions (e.g., Module 2 and 5 deliverables) is a plus
• Familiarity with CAPA documentation and inspection-readiness processes, including Medical Writing’s role in supporting inspection responses, is a plus

Responsibilities

• Support development of the Investigator’s Brochure SOP and associated templates, including internal guidance documents and process aids
• Coordinate and track CSR appendices in partnership with cross-functional teams
• Oversee document review coordination, including preparing and aligning reviewer rosters
• Coordinate QC activities for clinical and regulatory documents, including working with external vendors to ensure timelines and deliverables are met
• Ensure QC-reviewed and final documents are properly archived and traceable in Veeva
• Develop and maintain document trackers for version history, ownership, and approvals to support audit readiness
• Support documentation and tracking activities for audit and inspection readiness, including CAPA follow-up
• Provide coordination and process support across Medical Writing deliverables to enable consistent documentation practices and compliance

Benefits

• bonus
• benefits
• participation in Company’s stock plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed