Contractor Medical Writing Operations Manager
Kyverna is hiring a remote Contractor Medical Writing Operations Manager. The career level for this job opening is Manager and is accepting USA based applicants remotely. Read complete job description before applying.
Kyverna
Job Title
Medical Writing Operations Manager
Posted
Career Level
Contractor
Career Level
Manager
Locations Accepted
USA
Salary
HOUR $70 - $80
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Job Details
Kyverna Therapeutics is focused on developing cell therapies for patients suffering from autoimmune diseases.
The Medical Writing Operations Manager will drive operational excellence and consistency across Medical Writing deliverables.
This role is responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment.
Responsibilities:
- Support development of the Investigator’s Brochure SOP and associated templates.
- Coordinate and track CSR appendices in partnership with cross-functional teams.
- Oversee document review coordination.
- Coordinate QC activities for clinical and regulatory documents.
- Ensure QC-reviewed and final documents are properly archived and traceable in Veeva.
- Develop and maintain document trackers.
- Support documentation and tracking activities for audit and inspection readiness.
- Provide coordination and process support across Medical Writing deliverables.
Qualifications:
- 7+ years in medical or regulatory writing operations within a GxP environment
- Hands-on SOP authorship and routing experience.
- Strong coordination and document control experience across review cycles, including experience with Veeva.
- Experience coordinating CSR appendices and other cross-functional components of BLA submissions is a plus
- Excellent attention to detail and organizational skills.
- Strong interpersonal and communication skills.
- Exposure to regulatory submissions (INDs, BLAs, CTDs)
- Well-versed in inspection-readiness documentation practices
- Familiarity with CAPA documentation and inspection-readiness processes.
FAQs
What is the last date for applying to the job?
The deadline to apply for Contractor Medical Writing Operations Manager at Kyverna is
6th of December 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
USA
] applicants. .