Medical Writing Operations Manager (Contract) - Remote

Overview

The Medical Writing Operations Manager will drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions at Kyverna Therapeutics, a biopharmaceutical company focused on developing cell therapies for autoimmune diseases.

In Short

• Drive operational excellence in Medical Writing.
• Coordinate document management and control.
• Support SOP authorship and template maintenance.
• Ensure compliance with regulatory standards.
• Manage document review processes and QC activities.
• Track version history and approvals for audit readiness.
• Collaborate with cross-functional teams.
• Maintain documentation practices for inspection readiness.
• Occasional travel to Bay Area for key meetings.
• Contract position for 6+ months.

Requirements

• 7+ years in medical or regulatory writing operations.
• Experience in a GxP environment.
• Hands-on SOP authorship experience.
• Strong document control and coordination skills.
• Familiarity with Veeva or similar systems.
• Excellent attention to detail and organizational skills.
• Strong interpersonal and communication skills.
• Exposure to regulatory submissions (INDs, BLAs).
• Knowledge of inspection-readiness documentation practices.
• Familiarity with CAPA documentation processes.

Benefits

• Opportunity to work at the forefront of cell therapy innovation.
• Collaborate with industry veterans and healthcare visionaries.
• Flexible work arrangements.
• Gain experience in a fast-paced biopharmaceutical environment.
• Contribute to meaningful advancements in autoimmune disease treatment.