Medical Writing Operations Manager – Contract

October 29

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Kyverna Therapeutics

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Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

📋 Description

• Drive operational excellence and consistency across Medical Writing deliverables in support of inspection readiness and regulatory submissions • Responsible for document coordination and control, SOP authorship support, template maintenance, and process aid development, version management, and cross-functional alignment • 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

🎯 Requirements

• 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