Senior Manager, Medical Writing
Travere Therapeutics
June 27, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Clinical Research and Development
Position Summary:
- Senior Manager, Medical Writing responsible for authoring, managing, and leading regulatory, clinical, and safety document development, including protocols/amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission documents.
- Provide regulatory writing subject-matter expertise and cross-functional leadership to ensure documents are scientifically accurate, compliant, and delivered on timeline.
- Deliver medical writing strategy and leadership across clinical development and post-marketing lifecycle management, driving process improvements and best practices.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety documents with accuracy and compliance.
- Lead cross-functional collaborations to develop/review/finalize documents for clinical programs and regulatory submissions.
- Manage timelines, review cycles, and comment resolution to meet milestones.
- Interpret/analyze/summarize complex clinical and scientific data for submission-ready content.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Lead continuous improvements of medical writing processes, templates, style guides, and SOPs; drive program alignment.
- Develop/maintain expertise in therapeutic areas and products.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field (equivalency considered).
- Advanced degree (MS, PharmD, PhD) preferred.
- 7+ years in medical/regulatory writing, document management/publishing/operations (biotech/pharma/CRO or related).
- Leadership experience authoring complex clinical/regulatory documents.
- Strong knowledge of global drug development and regulatory requirements.
Additional Skills/Requirements:
- Expert scientific writing/editing/communication; attention to detail and quality.
- Proficiency with Microsoft Office, Veeva, and electronic document management systems.
- Strong project management; manage multiple priorities and deliver on timelines.
- Ability to work independently and collaborate cross-functionally.
- Excellent interpersonal and communication skills for technical/non-technical audiences.
- Ability to travel up to 10%.
- Not fully remote; must be able to perform face-to-face/onsite in San Diego.
Total Rewards/Benefits:
- Premium health and financial/work-life benefits, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off.
- Target base pay range: $132,000–$172,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
- Senior Manager, Medical Writing responsible for authoring, managing, and leading regulatory, clinical, and safety document development, including protocols/amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission documents.
- Provide regulatory writing subject-matter expertise and cross-functional leadership to ensure documents are scientifically accurate, compliant, and delivered on timeline.
- Deliver medical writing strategy and leadership across clinical development and post-marketing lifecycle management, driving process improvements and best practices.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety documents with accuracy and compliance.
- Lead cross-functional collaborations to develop/review/finalize documents for clinical programs and regulatory submissions.
- Manage timelines, review cycles, and comment resolution to meet milestones.
- Interpret/analyze/summarize complex clinical and scientific data for submission-ready content.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Lead continuous improvements of medical writing processes, templates, style guides, and SOPs; drive program alignment.
- Develop/maintain expertise in therapeutic areas and products.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field (equivalency considered).
- Advanced degree (MS, PharmD, PhD) preferred.
- 7+ years in medical/regulatory writing, document management/publishing/operations (biotech/pharma/CRO or related).
- Leadership experience authoring complex clinical/regulatory documents.
- Strong knowledge of global drug development and regulatory requirements.
Additional Skills/Requirements:
- Expert scientific writing/editing/communication; attention to detail and quality.
- Proficiency with Microsoft Office, Veeva, and electronic document management systems.
- Strong project management; manage multiple priorities and deliver on timelines.
- Ability to work independently and collaborate cross-functionally.
- Excellent interpersonal and communication skills for technical/non-technical audiences.
- Ability to travel up to 10%.
- Not fully remote; must be able to perform face-to-face/onsite in San Diego.
Total Rewards/Benefits:
- Premium health and financial/work-life benefits, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off.
- Target base pay range: $132,000–$172,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.