Clinical Documentation Lead (Biotech)

Location: South San Francisco, California, United States; onsite presence is expected at least 3 days per week.

Salary: $113,800–$211,400 annually, with a discretionary annual bonus potentially available.

Company

hirify.global, a member of the Roche group, is a biotechnology company developing medicines for serious and life-threatening diseases.

What you will do

• Lead medical writing, editing, and project management for clinical documents.
• Oversee the development of study protocols, informed consent forms, abstracts, manuscripts, and scientific statements.
• Create and maintain project timelines while coordinating authoring teams and review cycles.
• Manage review-comment adjudication, publishing, signoff, and document archiving.
• Partner with Clinical Science, Safety Science, Regulatory, and Clinical Operations stakeholders across the Roche organization.
• Explore AI-based solutions and innovative technologies to improve medical writing and editing workflows.

Requirements

• At least eight years of medical writing and clinical project management experience, preferably in biotechnology or pharmaceuticals.
• Expertise in clinical, scientific, and/or regulatory writing, including leadership of complex document authoring, review, and finalization.
• Strong project management and team facilitation skills, including consensus-building under pressure.
• Exceptional written and oral communication skills with the ability to work effectively with organizational stakeholders.
• Strong analytical, planning, and organizational skills, including management of high-volume, simultaneous workflows under tight deadlines.
• Master’s degree or PhD in a scientific, life sciences, or liberal arts discipline is preferred, or equivalent experience.

Culture & Benefits

• Work within an Early Clinical Development team focused on pioneering therapies.
• Collaborate across clinical, safety, regulatory, and operational functions.
• Benefits are provided for the regular employment position.
• The employer is committed to equal opportunity and nondiscrimination.