Sr Manager, Medical Writing

Kyverna Therapeutics, Inc.; Northern (KY); Hybrid; USD 170,000 - 190,000; Full time

Benefits offered by this job

Bonus eligible

Stock plan participation

Benefits

Job summary

Kyverna Therapeutics, Inc. is seeking a Senior Manager, Medical Writer to provide regulatory medical writing support for development programs, including FDA interactions and RMAT/Breakthrough Therapy planning.

The role emphasizes independent authorship of complex regulatory documents and collaboration across Clinical Development, Regulatory Affairs, and cross-functional teams. The ideal candidate has 10+ years in medical writing within biotech/pharma, advanced life sciences training, and strong

Qualifications

• Advanced degree in Life Sciences or related field preferred.
• 10+ years of medical writing experience in biotech/pharma.
• Extensive experience independently authoring FDA regulatory documents.
• Proven experience developing FDA briefing documents (RMAT, Breakthrough Therapy).
• Strong experience drafting clinical protocols and synopses.
• Thorough understanding of FDA regulations, ICH guidelines, and GCP.
• Ability to manage multiple projects with minimal supervision.
• Exceptional scientific writing, editing, and communication skills.
• Experience in fast-paced cross-functional clinical development environments.

Responsibilities

• Independently author, edit, and finalize complex regulatory documents for development programs.
• Lead development of FDA briefing documents for RMAT, Breakthrough Therapy, and other regulatory interactions.
• Develop clinical protocol synopses and support full protocol development for studies.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other teams to synthesize information.
• Drive document timelines, coordinate reviews, and deliver high-quality documents on schedule.
• Ensure alignment with FDA guidance, ICH guidelines, and company standards.
• Participate in document planning meetings and provide input on structure and messaging.
• Support additional regulatory and clinical documents as needed.

Skills

Regulatory writing

Cross-functional collaboration

Project management

Scientific communication

Clinical development familiarity

Education

PhD / PharmD / MD or equivalent

Job description

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Sr Manager, Medical Writing

Reports to: Sr. Director, Medical Writing
Location: Remote, United States (West coast hours preferred)

Position Summary

Kyverna is seeking an experienced Senior Manager, Medical Writer to provide regulatory medical writing support for development programs. This individual will serve as an independent contributor responsible for developing high-quality regulatory documents supporting FDA interactions and clinical development activities.

The ideal candidate brings extensive medical writing experience in Autoimmune diseases (Stiff Person Syndrome, Myasthenia Gravis, Progressive Multiple Sclerosis) and has a proven ability to independently author complex regulatory documents with minimal oversight. This role will partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional stakeholders to support critical regulatory milestones.

Responsibilities

• Independently author, edit, and finalize complex regulatory documents supporting clinical development programs, ensuring scientific accuracy, consistency, and compliance with regulatory requirements.
• Lead development of FDA briefing documents, including materials supporting RMAT, Breakthrough Therapy Designation, and other Agency interactions.
• Develop clinical protocol synopses and contribute to full protocol development for clinical studies.
• Collaborate withClinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other functional teams to gather, interpret, and synthesize scientific and clinical information.
• Drive document development timelines, proactively managing reviews, incorporating cross-functional feedback, and delivering high-quality documents on schedule.
• Ensure documents are aligned with FDA guidance, ICH guidelines, and company standards.
• Participate in document planning meetings and provide strategic input on document structure, messaging, and regulatory presentation.
• Support additional regulatory and clinical documents as business needs evolve.

Qualifications

• Advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related scientific discipline preferred.
• 10+ years of medical writing experience within the biotechnology or pharmaceutical industry.
• Extensive experience independently authoring FDA regulatory documents, including briefing packages, meeting requests, and clinical development documents.
• Proven 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 independently manage multiple projects with minimal supervision while meeting aggressive timelines.
• Exceptional scientific writing, editing, communication, and project management skills.
• Experience working in fast-paced, cross-functional clinical development environments.

The national salary range for this position is $170K to $190K USD annually. The salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.