Senior Manager, Medical Writing
Travere Therapeutics
August 08, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary:
The Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents (including protocols/protocol amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission-related documents). Provides regulatory writing subject matter expertise and cross-functional strategic guidance to ensure documents are scientifically accurate, compliant with applicable regulations, and delivered on time. Provides medical writing strategy and leadership across clinical development and post-marketing lifecycle management, driving process improvements and advancement of standards/best practices.
Responsibilities:
- Author/coordinate preparation of regulatory, clinical, and safety documents ensuring accuracy, consistency, and compliance.
- Lead cross-functional collaborations to develop, review, and finalize documents for clinical programs and regulatory submissions.
- Manage document timelines, review cycles, and comment resolution to meet milestones.
- Interpret/analyze/summarize complex clinical and scientific data into submission-ready content.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Lead continuous improvements to medical writing processes, templates, style guides, and SOPs.
- Develop/maintain expertise in assigned therapeutic areas/products.
- Additional duties as assigned.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field (or equivalent experience).
- Advanced degree (MS, PharmD, PhD) preferred.
- 7+ years relevant experience in medical writing/regulatory writing/document management within biotech/pharma/CRO.
- Leadership experience authoring complex clinical and regulatory documents.
- Strong knowledge of drug development processes and global regulatory requirements.
Additional Skills/Requirements:
- Expert scientific writing/editing/communication with high attention to detail.
- Knowledge of FDA/EMA/ICH and clinical development/regulatory guidance.
- Proficiency with Microsoft Office, Veeva, and electronic document management systems.
- Strong project management/organizational skills; ability to manage multiple priorities.
- Ability to work independently and collaborate cross-functionally.
- Excellent interpersonal and written/verbal communication skills.
- Ability to travel up to 10%.
- Not 100% remote; must be able to perform face-to-face/onsite in San Diego.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
Compensation:
- Target base pay range: $132,000.00 - $172,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents (including protocols/protocol amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission-related documents). Provides regulatory writing subject matter expertise and cross-functional strategic guidance to ensure documents are scientifically accurate, compliant with applicable regulations, and delivered on time. Provides medical writing strategy and leadership across clinical development and post-marketing lifecycle management, driving process improvements and advancement of standards/best practices.
Responsibilities:
- Author/coordinate preparation of regulatory, clinical, and safety documents ensuring accuracy, consistency, and compliance.
- Lead cross-functional collaborations to develop, review, and finalize documents for clinical programs and regulatory submissions.
- Manage document timelines, review cycles, and comment resolution to meet milestones.
- Interpret/analyze/summarize complex clinical and scientific data into submission-ready content.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Lead continuous improvements to medical writing processes, templates, style guides, and SOPs.
- Develop/maintain expertise in assigned therapeutic areas/products.
- Additional duties as assigned.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field (or equivalent experience).
- Advanced degree (MS, PharmD, PhD) preferred.
- 7+ years relevant experience in medical writing/regulatory writing/document management within biotech/pharma/CRO.
- Leadership experience authoring complex clinical and regulatory documents.
- Strong knowledge of drug development processes and global regulatory requirements.
Additional Skills/Requirements:
- Expert scientific writing/editing/communication with high attention to detail.
- Knowledge of FDA/EMA/ICH and clinical development/regulatory guidance.
- Proficiency with Microsoft Office, Veeva, and electronic document management systems.
- Strong project management/organizational skills; ability to manage multiple priorities.
- Ability to work independently and collaborate cross-functionally.
- Excellent interpersonal and written/verbal communication skills.
- Ability to travel up to 10%.
- Not 100% remote; must be able to perform face-to-face/onsite in San Diego.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
Compensation:
- Target base pay range: $132,000.00 - $172,000.00.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.