Senior Director, Medical Writing
Zenas BioPharma
August 07, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary
- Senior Director, Medical Writing (MW): Lead and/or write scientifically rigorous, logically organized regulatory and clinical documents with accurate data presentation/interpretation, ensuring timely delivery per program goals and regulatory requirements. Independently lead pertinent sections of marketing authorization submissions; identify new/unique document types requiring different approaches. Partner with and report to the Executive Director, Medical Writing.
Key Responsibilities
- Provide strategic leadership and continual process improvement/innovation for regulatory document medical writing.
- Ensure deliverables are appropriately resourced; escalate critical issues; drive sound strategic direction for regulatory submissions.
- May manage medical writing staff and oversee vendors/contractors; mentor and guide prioritization, content, timelines, and process management.
- Partner with Legal and Finance to negotiate medical writing contracts and develop budgets.
- Oversee external vendors/contractors (resource forecasting, contract change management, vendor financial oversight).
- Oversee contract resources to ensure on-time project completion (define/review scopes of work).
- Oversee clinical trial transparency documents and vendor oversight.
- Maintain SOPs, best practices, templates, style guides, reference library, and QC checklists.
- Lead through example; pivot strategy quickly in a fast-paced start-up environment.
Qualifications
- BS in a scientific discipline or equivalent; MS preferred.
- 12+ years medical writing experience (pharma/biopharma/CRO).
- Extensive knowledge of English grammar and AMA style.
- Prior direct experience leading global marketing authorization medical writing teams.
- Expert knowledge of drug development, clinical research, study design, biostatistics, regulatory requirements, medical terminology.
- Proficiency with Microsoft Office, Adobe Acrobat, eDMS, templates, PM tools, and reference management tools.
- Comfortable hands-on work while building scalable infrastructure.
- Travel to HQ every three months or as needed (up to 15%).
Compensation/Benefits (if applicable)
- Base salary range: $219,400–$274,300; total rewards include annual performance bonus, equity, full benefits, and other incentive compensation plans.
- Senior Director, Medical Writing (MW): Lead and/or write scientifically rigorous, logically organized regulatory and clinical documents with accurate data presentation/interpretation, ensuring timely delivery per program goals and regulatory requirements. Independently lead pertinent sections of marketing authorization submissions; identify new/unique document types requiring different approaches. Partner with and report to the Executive Director, Medical Writing.
Key Responsibilities
- Provide strategic leadership and continual process improvement/innovation for regulatory document medical writing.
- Ensure deliverables are appropriately resourced; escalate critical issues; drive sound strategic direction for regulatory submissions.
- May manage medical writing staff and oversee vendors/contractors; mentor and guide prioritization, content, timelines, and process management.
- Partner with Legal and Finance to negotiate medical writing contracts and develop budgets.
- Oversee external vendors/contractors (resource forecasting, contract change management, vendor financial oversight).
- Oversee contract resources to ensure on-time project completion (define/review scopes of work).
- Oversee clinical trial transparency documents and vendor oversight.
- Maintain SOPs, best practices, templates, style guides, reference library, and QC checklists.
- Lead through example; pivot strategy quickly in a fast-paced start-up environment.
Qualifications
- BS in a scientific discipline or equivalent; MS preferred.
- 12+ years medical writing experience (pharma/biopharma/CRO).
- Extensive knowledge of English grammar and AMA style.
- Prior direct experience leading global marketing authorization medical writing teams.
- Expert knowledge of drug development, clinical research, study design, biostatistics, regulatory requirements, medical terminology.
- Proficiency with Microsoft Office, Adobe Acrobat, eDMS, templates, PM tools, and reference management tools.
- Comfortable hands-on work while building scalable infrastructure.
- Travel to HQ every three months or as needed (up to 15%).
Compensation/Benefits (if applicable)
- Base salary range: $219,400–$274,300; total rewards include annual performance bonus, equity, full benefits, and other incentive compensation plans.