United States onlyKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
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.
Title: Medical Writing Operations Manager (Contract)
Location: Remote (with occasional travel to Bay Area as needed for key meetings, inspection preparation or activities)
Reporting to: Director of Medical Writing
Term: 6+ months
Hourly Range: $70/hr-$80/hr
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
Qualifications
- 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
- Experience coordinating CSR appendices and other cross-functional components of BLA submissions (e.g., Module 2 and 5 deliverables) is a plus
- 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
- Familiarity with CAPA documentation and inspection-readiness processes, including Medical Writing’s role in supporting inspection responses, is a plus
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
