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 2025-11-08
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 Live Chat Support Representative – Delivering Exceptional Customer Experiences through Timely Solutions and Product Expertise at blithequark

    Remote, USA Full-time

    Experienced Customer Support Specialist II – Delivering Exceptional Client Experiences through Proactive Solutions and Expert Guidance

    Remote, USA Full-time

    **Experienced Customer Service Representative – Propane Industry Expert**

    Remote, USA Full-time

    Assoc Delivery Cons - App/Dev, A2C ProServe Shared Delivery (SDT)

    Remote, USA Full-time

    Sr Labor Strategy Consultant

    Remote, USA Full-time

    [Remote] Escalation Specialist , NA AMOC

    Remote, USA Full-time

    Experienced Organ Placement Coordinator – Night Shift Opportunity for Maximizing Organ Utilization and Saving Lives through Donation and Transplantation

    Remote, USA Full-time

    Virtual Patient Observation Attendant

    Remote, USA Full-time

    Experienced Part-Time Remote Veterinary Receptionist - Provide Exceptional Client Care and Support to Compassionate Veterinary Teams Across the US

    Remote, USA Full-time

    Career with American Airlines:Flight Attendant | Hiring

    Remote, USA Full-time

    Experienced Part-Time Evening Work From Home Data Entry Specialist – Flexible and Convenient Opportunity for Remote Work

    Remote, USA Full-time

    Experienced Data Entry Specialist – Flexible Work-From-Home Opportunity with Amazon, No Prior Experience Required

    Remote, USA Full-time

    **Experienced Netflix Remote Data Entry Specialist – Content Management and Quality Assurance**

    Remote, USA Full-time

    Experienced Customer Care Specialist for Travel - Remote Opportunity with blithequark

    Remote, USA Full-time

    **Experienced Data Entry Specialist – Online Remote Amazon Data Entry Jobs – Hiring Now**

    Remote, USA Full-time

    **Experienced Data Entry Specialist – Remote Work Opportunity with American Express**

    Remote, USA Full-time

    **Experienced Customer Service Manager - Virtual: Lead a High-Performing Team in Delivering Exceptional Customer Experiences**

    Remote, USA Full-time

    Experienced Data Entry Specialist – Remote Opportunity with American Express: Join a Global Leader in Financial Services

    Remote, USA Full-time

    **Experienced Entry-Level Data Entry Specialist – Remote Opportunity with American Express**

    Remote, USA Full-time

    **Experienced Full Stack Data Entry Specialist – Amazon Operations Support Team**

    Remote, USA Full-time