Director, Medical Writing (Biotech)

Location: Hybrid in South San Francisco, California, with an expectation to be onsite at the headquarters at least three days per week.

Salary: $223,000–$271,000 annual base salary for employees located in the San Francisco Bay Area, plus eligibility for an annual performance bonus.

Company

hirify.global is a clinical-stage biopharmaceutical company using human genetics to develop precision medicines for kidney and metabolic diseases.

What you will do

• Lead the medical writing function and oversee clinical and regulatory documents across development programs.
• Develop protocols, clinical study reports, health authority meeting materials, and submission-supporting content.
• Manage medical writing vendors and external partners to deliver high-quality documents on schedule.
• Collaborate with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, Safety, Quality, CMC, and external partners.
• Translate protocols, SAPs, TFLs, and safety and efficacy outputs into clear, accurate, and defensible regulatory documents.
• Establish medical writing standards, templates, review practices, structured content, automation, and AI-enabled workflows with human oversight and traceability.

Requirements

• 8–10+ years of progressive regulatory medical writing experience in the biopharmaceutical industry.
• Bachelor’s degree in a scientific, medical, or health-related discipline with significant relevant experience; an advanced degree is preferred.
• Experience developing clinical and regulatory documents across the development lifecycle; late-stage development and NDA, BLA, or MAA experience is preferred.
• Strong understanding of drug development, clinical trial design, regulatory requirements, and FDA, ICH, EMA, and other applicable guidance.
• Ability to interpret and communicate clinical data using protocols, SAPs, TFLs, safety and efficacy outputs, and related clinical study materials.
• Experience managing external medical writing resources and working cross-functionally in a hands-on development environment.

Nice to have

• Sponsor-side or sponsor-embedded medical writing experience.
• Practical familiarity with structured content, content reuse, document automation, or AI-enabled tools for medical writing.

Culture & Benefits

• Collaborative environment focused on precision medicines and improving treatment for patients with severe genetic diseases.
• Culture emphasizing resilience, teamwork, initiative, integrity, and creative thinking.
• Medical, dental, vision, and mental health benefits for eligible employees.
• Equity incentive plan and 401(k) program with employer match.
• Generous holiday and paid time off policy.