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Medical Writing Operations Manager
<p> </p><p>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.</p> <p><strong>Position Summary</strong></p> <p>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.</p> <p><strong>Title:</strong> Medical Writing Operations Manager</p> <p><strong>Reports to:</strong> Director of Medical Writing</p> <p><strong>Location:</strong> Emeryville, CA (Hybrid) or West Coast remote</p> <p></p> <p></p><p><br></p><b>Responsibilities</b><ul> <li>Support development of the Investigator’s Brochure SOP and associated templates, including internal guidance documents and process aids</li> <li>Coordinate and track CSR appendices in partnership with cross-functional teams</li> <li>Oversee document review coordination, including preparing and aligning reviewer rosters</li> <li>Coordinate QC activities for clinical and regulatory documents, including working with external vendors to ensure timelines and deliverables are met</li> <li>Ensure QC-reviewed and final documents are properly archived and traceable in Veeva</li> <li>Develop and maintain document trackers for version history, ownership, and approvals to support audit readiness</li> <li>Support documentation and tracking activities for audit and inspection readiness, including CAPA follow-up</li> <li>Provide coordination and process support across Medical Writing deliverables to enable consistent documentation practices and compliance</li> </ul><p><br></p><b>Qualifications</b><ul> <li>7+ years in medical or regulatory writing operations within a GxP environment</li> <li>Hands-on SOP authorship and routing experience, ideally with DOT or similar systems</li> <li>Strong coordination and document control experience across review cycles, including experience with Veeva or similar regulatory document management systems</li> <li>Experience coordinating CSR appendices and other cross-functional components of BLA submissions (e.g., Module 2 and 5 deliverables) is a plus</li> <li>Excellent attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines</li> <li>Strong interpersonal and communication skills, with proven ability to build trust across cross-functional teams</li> <li>Exposure to regulatory submissions (INDs, BLAs, CTDs)</li> <li>Well-versed in inspection-readiness documentation practices</li> <li>Familiarity with CAPA documentation and inspection-readiness processes, including Medical Writing’s role in supporting inspection responses, is a plus</li> </ul><p><br></p><p></p> <p> </p><p>The national salary range for this position is from $125K to $140K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.</p> <p></p>
