Director, Medical Writing

Director, Medical Writing

Kezar Life Sciences is seeking an experienced Director, Medical Writing to support its investigational drug programs. This position will report to the Vice President of Regulatory Affairs. This is a highly visible role, responsible for driving and shaping the medical writing processes, procedures, strategies, and document maintenance. This individual will lead all medical writing activities at Kezar and will manage contract writers and document QC experts, as well as workflows for document development in Veeva Vault. Key accountabilities include providing guidance on scientific and technical requirements for regulatory documents, developing and maintaining a style guide for Kezar, and following best practices for authoring of key regulatory documents to meet global regulatory standards. The expectation is to be onsite at our South San Francisco, CA office at least three days per week.

Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation.

Key Responsibilities include:

• Write IND modules, NDA modules and other related regulatory documents
• Write clinical study reports, protocols, and protocol amendments
• Coordinate quality control reviews of those documents and maintain audit trails of changes
• Manage contract medical writers and document QC experts
• Develop processes and procedures to establish efficiencies during document development
• Contribute to manuscripts, abstracts, and poster development, as needed
• Develop a medical writing style guide for Kezar
• Collaborate with cross-functional team members (e.g., biometrics) to ensure related documents such as statistical analysis plans and draft tables, figures, and listings, are appropriate and provide appropriate information/data for a CSR
• Liaise with appropriate SMEs to shape and review document content and follow up with various functional groups for required source material
• Train SMEs on proper authoring and review of documents and use of document templates
• Work closely with regulatory strategy leads and regulatory operations teams
• Supervising writing projects, and for knowing, understanding, and ensuring adherence to regulatory guidelines and department document standards

Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.

Preferred Qualifications Include:

• Advanced degree (Ph.D. or PharmD) combined with 10+ years of medical writing experience in the clinical research or biotechnology industry.
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management preferred)
• Strong computer skills, project management skills, and a high attention to detail
• Experience with StartingPoint templates and Veeva Vault, preferred
• Strong communication skills (both written and oral)
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
• Expert-level skills w/ Microsoft Word and PowerPoint

Compensation and Benefits

The salary range for this position as Director at our South San Francisco, CA corporate office is $215,000 - $230,000. Factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: Join Our Team - Kezar Life Sciences Inc.

About Kezar Life Sciences

We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Since inception, our mission has been to del