Director, Medical Writing
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$222,000 - $258,000 USD yearly
Clinical Research and Development
Responsibilities
- Lead medical writing efforts and strategy for clinical and strategic regulatory documents, ensuring high quality and on-time deliverables per applicable regulations, Good Clinical Practices, and SOPs (e.g., health authority briefing packages, pediatric plans, designation requests, clinical protocols, investigator brochures, clinical study reports, IND/BLA summary documents).
- Serve as document lead for regulatory document creation, review, and approval.
- Develop plans and timelines for regulatory document initiation and completion.
- Partner with cross-functional leads to interpret and present nonclinical and/or clinical data for regulatory submissions.
- Contribute to regulatory submission documents per applicable guidelines.
- Coordinate and drive adjudication of review comments; provide timely follow-up until resolution.
- Copy edit, proofread, and modify documents for organization, clarity, language/grammar, scientific standards, and consistency across text and listings/tabular/graphic displays.
- Perform technical editing (formatting) to align with company templates.
- Review statistical analysis plans and table/listing/figure shells for writing content appropriateness.
- Oversee and manage writing resources (external consultants and internal hires as needed); train writers on SOPs/procedures; coach/mentor junior staff.
Qualifications
- Bachelor’s degree+ in life sciences/pharmacy/medicine or related field; PhD/PharmD preferred.
- 8+ years of relevant medical writing experience, including critical analysis and scientific data summarization.
- Strong experience authoring clinical and strategic regulatory documents (e.g., briefing packages, fast track/breakthrough designation requests).
- Experience authoring key clinical summary documents supporting NDA/BLA and/or MAA submissions.
- Knowledge of drug development process; working knowledge of ICH and FDA/EMA requirements.
- Proficient with MS Office (Word/Excel/PowerPoint), document management systems, and electronic templates.
Core competencies
- Exceptional written/verbal communication; high attention to detail.
- Ability to work independently and collaboratively in fast-paced cross-functional teams.
- Strong influence management; flexible with changing priorities.
Compensation Range
- $222K - $258K
- Lead medical writing efforts and strategy for clinical and strategic regulatory documents, ensuring high quality and on-time deliverables per applicable regulations, Good Clinical Practices, and SOPs (e.g., health authority briefing packages, pediatric plans, designation requests, clinical protocols, investigator brochures, clinical study reports, IND/BLA summary documents).
- Serve as document lead for regulatory document creation, review, and approval.
- Develop plans and timelines for regulatory document initiation and completion.
- Partner with cross-functional leads to interpret and present nonclinical and/or clinical data for regulatory submissions.
- Contribute to regulatory submission documents per applicable guidelines.
- Coordinate and drive adjudication of review comments; provide timely follow-up until resolution.
- Copy edit, proofread, and modify documents for organization, clarity, language/grammar, scientific standards, and consistency across text and listings/tabular/graphic displays.
- Perform technical editing (formatting) to align with company templates.
- Review statistical analysis plans and table/listing/figure shells for writing content appropriateness.
- Oversee and manage writing resources (external consultants and internal hires as needed); train writers on SOPs/procedures; coach/mentor junior staff.
Qualifications
- Bachelor’s degree+ in life sciences/pharmacy/medicine or related field; PhD/PharmD preferred.
- 8+ years of relevant medical writing experience, including critical analysis and scientific data summarization.
- Strong experience authoring clinical and strategic regulatory documents (e.g., briefing packages, fast track/breakthrough designation requests).
- Experience authoring key clinical summary documents supporting NDA/BLA and/or MAA submissions.
- Knowledge of drug development process; working knowledge of ICH and FDA/EMA requirements.
- Proficient with MS Office (Word/Excel/PowerPoint), document management systems, and electronic templates.
Core competencies
- Exceptional written/verbal communication; high attention to detail.
- Ability to work independently and collaboratively in fast-paced cross-functional teams.
- Strong influence management; flexible with changing priorities.
Compensation Range
- $222K - $258K