Director, Medical Writing

Bicara Therapeutics•Boston, MA

21h

About The Position

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.

Requirements

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.
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

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
Coordinates and drives the adjudication of review comments with other authors and reviewers and provides timely follow-up to address outstanding queries or comments until resolution
Copy edits and 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
Review 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. Ensure training on SOPs/procedures for all writers; provide coaching and mentorship for junior staff.