Associate Director, Regulatory & Medical Writing (Biopharma)

Location: Onsite in Brisbane, California, United States

Salary: $216,400–$234,800 per year for roles based in the San Francisco Bay Area

Company

Clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases using an AI-integrated discovery engine.

What you will do

• Author and oversee regulatory and medical writing documents across clinical development programs.
• Develop clinical protocols, clinical study reports, investigator’s brochures, lay summaries, integrated reports, and health authority submissions.
• Review, edit, and quality-control documents prepared by other authors and medical writers.
• Manage authoring, review, and approval workflows for multiple deliverables while maintaining consistency, quality, messaging, format, and timelines.
• Lead writing activities for assigned programs, including resource planning, issue resolution, process improvement, and external resource management.
• Represent Regulatory & Medical Writing on interdisciplinary teams and provide strategic input and status updates.

Requirements

• 6–8+ years of regulatory or medical writing experience, or relevant pharmaceutical or biotechnology industry experience in clinical development.
• Experience authoring and overseeing documents submitted to health authorities, including protocols, investigator’s brochures, clinical study reports, lay summaries, and informed consent forms.
• Knowledge of health authority requirements, ICH guidelines, eCTD, and submission lifecycle management.
• Ability to lead cross-functional working groups and manage multiple shifting priorities with strong organization and attention to detail.
• Proficiency with MS Project or Smartsheet, collaborative authoring and document review tools, and Veeva RIM Suite.
• Expertise in Microsoft Word, customized templates and toolbars, and document management systems.

Nice to have

• Experience with ex-US submissions for clinical trial applications and marketing applications.

Culture & Benefits

• Highly collaborative, team-oriented environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful working style.
• Openness to diverse points of view.