Director, Medical Writing

Responsibilities

• Lead medical writing strategy for clinical and strategic regulatory documents including briefing packages, pediatric plans, and IND/BLA summary documents
• Act as document lead for the creation, review, and approval process of regulatory documentation
• Develop plans and timelines for regulatory document initiation and completion in collaboration with project teams
• Partner with cross-functional leads to interpret and present nonclinical and clinical data
• Coordinate and adjudicate review comments with authors and reviewers
• Perform copy editing, proofreading, and technical editing to ensure scientific standards and consistency
• Review Statistical Analysis Plans and table, listing, and figure shells
• Oversee and manage resources, including external consultants and internal staff, providing coaching and mentorship

Requirements

• Bachelor's degree or higher in life sciences, pharmacy, medicine, or a related field
• 8+ years of relevant medical writing experience analyzing and summarizing scientific data
• Strong experience authoring clinical and strategic regulatory documents (e.g., briefing packages, designation requests)
• Experience authoring key clinical summary documents for NDA/BLA and/or MAA submissions
• Knowledge of the drug development process and ICH guidelines
• Working knowledge of FDA/EMA regulatory requirements
• Proficiency with MS Office Suite and document management systems

Preferred Qualifications

• Advanced degree (PhD, PharmD)

About the Company

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Headquartered in Boston, the company focuses on advancing innovative therapies designed to deliver superior efficacy and improved safety in solid tumor treatment.