Medical Writer, Regulatory – Contract

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

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.

📋 Description

• Independently author, edit, and finalize complex regulatory documents supporting clinical development programs • Lead development of FDA briefing documents supporting RMAT, Breakthrough Therapy Designation, and other Agency interactions • Develop clinical protocol synopses and contribute to full protocol development • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other functional teams • Manage document development timelines, reviews, cross-functional feedback, and delivery schedules • Ensure documents align with FDA guidance, ICH guidelines, and company standards • Participate in document planning meetings and provide strategic input on structure, messaging, and regulatory presentation • Support additional regulatory and clinical documents as business needs evolve

🎯 Requirements

• 10+ years of medical writing experience in the biotechnology or pharmaceutical industry • Extensive experience independently authoring FDA regulatory documents, including briefing packages, meeting requests, and clinical development documents • Experience developing FDA briefing documents supporting RMAT, Breakthrough Therapy Designation, or similar regulatory interactions • Strong experience writing clinical protocols and protocol synopses • Thorough understanding of FDA regulations, ICH guidelines, and GCP requirements • Ability to manage multiple projects independently with minimal supervision while meeting aggressive timelines • Exceptional scientific writing, editing, communication, and project management skills • Experience in fast-paced, cross-functional clinical development environments • Advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related scientific discipline preferred

🏖️ Benefits

• Flexible hours based on project demands • Potential contract extension based on business needs and regulatory timelines • Remote work within the United States