Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffe...">
Back to Jobs

Medical Writing Operations Manager

Remote, USA Full-time Posted 2026-06-04
Kyverna 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
    Apply To This Job

    Similar Jobs

    Experienced Customer Support Representative – Remote Position for Delivering Exceptional Service and Driving Customer Satisfaction

    Remote, USA Full-time

    Work Study Student from Loyola University

    Remote, USA Full-time

    Customer Service Representative in Recovery - T...

    Remote, USA Full-time

    Bilingual Spanish Call Center Rep - Hybrid

    Remote, USA Full-time

    **Experienced Data Entry Clerk – Military Recruitment and Advertising Strategies**

    Remote, USA Full-time

    IRB Administrator / TSRI- Human Research Protection Program / Full-time / Days

    Remote, USA Full-time

    Virtual Benefits Rep (fully remote)

    Remote, USA Full-time

    Dispatch (REMOTE) Greenville NC

    Remote, USA Full-time

    **Experienced Remote Data Entry Operator – Global E-commerce and Technology Giant**

    Remote, USA Full-time

    **Job Title:** Customer Service Advocate - Work from Home: Deliver Exceptional Insurance Solutions with blithequark

    Remote, USA Full-time

    Part-Time Evening Data Entry Specialist – Remote Work Opportunity for Detail-Oriented Professionals

    Remote, USA Full-time

    BCBA - Bilingual Full Time/Remote

    Remote, USA Full-time

    Remote Health & Life Insurance Brokers

    Remote, USA Full-time

    Remote Medical Scribe

    Remote, USA Full-time

    Postdoctoral Fellow (Remote-US) - Infectious Disease Epidemiology

    Remote, USA Full-time

    Conference Producer, Smarter Shows

    Remote, USA Full-time

    Pharmacist (100% Remote, Entry-level)

    Remote, USA Full-time

    Senior Manager, Payer Enrollment Strategy & Operations

    Remote, USA Full-time

    Oracle PL/SQL Developer, open to remote | 1044574

    Remote, USA Full-time

    **Experienced Virtual Customer Support Associate - arenaflex**

    Remote, USA Full-time