Director, Medical Writing

Position Overview

Responsibilities

Qualifications

Skills

Benefits

Pay

Schedule

Bicara Therapeutics is seeking a proactive and detail-oriented Director, Medical Writing to lead the development of complex, high-quality scientific documents that support our clinical development and regulatory submissions. Reporting to the VP, Regulatory Affairs, the ideal candidate will work closely with regulatory leadership, cross-functional teams and external partners to deliver accurate, clear, and compliant documentation on time. This role is ideal for an experienced Medical Writer who thrives in a small, fast-moving biotech environment. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Lead the Medical Writing efforts and strategy for clinical and strategic regulatory documents, ensuring high quality and on-time writing deliverables in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs).
• This includes but is not limited to health authority briefing packages, pediatric plans, designation requests, clinical protocols, investigator brochures, clinical study reports, and IND/BLA summary documents.
• Document lead for regulatory document creation, review and approval process.
• Works with project team members to develop a plan and timelines for regulatory document initiation and completion.
• Partner with cross-functional leads to interpret and present nonclinical and/or clinical data in documents for regulatory submission.
• Contributes to documents for regulatory submission in accordance with applicable regulatory guidelines.
• Copies edits, proofreads reviews, and modifies documents to ensure organization, clarity, use of language, grammar, scientific standards, and consistency between textual presentations and listings, tabular or graphic displays.
• Technical editing: Formats documents written by others to align with company templates. Reviews Statistical Analysis Plans and table, listing, and figure shells to determine appropriateness of content for writing.
• Directly oversee and manage resources to meet writing needs, including flexible use of consulting external writers or internal hires, as appropriate.
• Ensures training on SOPs/procedures for all writers; provides coaching and mentorship for junior staff.

Qualifications

• Bachelor's degree or higher in life sciences, pharmacy, medicine, or a related field; advanced degree (PhD, PharmD) preferred.
• 8+ years of relevant writing experience, including critically analyzing and summarizing scientific data.
• Strong experience authoring clinical and strategic regulatory documents (e.g., briefing packages, fast track/breakthrough designation requests).
• Experience authoring key clinical summary documents to support NDA/BLA and/or MAA submissions.
• Knowledge of the drug development process; working knowledge of relevant ICH guidelines and FDA/EMA regulatory requirements.
• Proficiency with MS Office Suite (Word, Excel, PowerPoint), document management systems, and use of electronic document templates.

Skills

• Exceptional written and verbal communication skills.
• High attention to detail, including fact-checking, logic flow and document structure.
• Ability to work independently and collaboratively in a fast-paced cross-functional team environment consisting of internal and external team members.
• Strong influence management skills as applied to cross-functional clinical teams.
• Flexible with changing priorities.

Benefits

• Flexible work schedule.
• Competitive compensation range: $222K - $258K.
• Health insurance coverage.
• Retirement savings plan.
• Professional development opportunities.
• Employee wellness programs.

Pay

• $222K - $258K

Schedule

• Hybrid schedule, with three in-office days each week.