Medical Writing Operations Manager (Contract)

Medical Writing Operations Manager (Contract)

Kvyerna 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.

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

Kvyerna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kvyerna 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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE / AA / Vets