Senior Manager, Medical Writing
Travere Therapeutics
August 30, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary:
Senior Manager, Medical Writing authoring, managing, and leading regulatory, clinical, and safety document development. Acts as subject matter expert in regulatory writing; partners cross-functionally to ensure documents are scientifically accurate, compliant, and delivered on timelines. Provides medical writing strategy across clinical development and post-marketing lifecycle management, including process improvement.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety documents (protocols/amendments, CSRs, IBs, CTD sections, briefing documents, other submission documents).
- Lead cross-functional collaboration to develop, review, and finalize high-quality documents.
- Manage document development timelines, review cycles, and comment resolution.
- Interpret and summarize complex clinical/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.
Qualifications:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required.
- 7+ years in medical/regulatory writing, document management/publishing/operations in biotech/pharma/CRO.
- Demonstrated leadership authoring complex clinical/regulatory documents; strong drug development and global regulatory knowledge.
Preferred:
- Advanced degree (MS, PharmD, PhD).
Skills/Requirements:
- Expert scientific writing/editing/communication with strong attention to detail and quality.
- Proficiency: Microsoft Office, Veeva, electronic document management systems.
- Strong project management/independent judgment; cross-functional collaboration.
- Ability to travel up to 10%; onsite in San Diego required (not 100% remote).
Benefits:
- Premium health, life insurance, disability, retirement match, generous paid time off, wellness/employee support.
Compensation:
- Target base pay range: $132,000–$172,000.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.
Senior Manager, Medical Writing authoring, managing, and leading regulatory, clinical, and safety document development. Acts as subject matter expert in regulatory writing; partners cross-functionally to ensure documents are scientifically accurate, compliant, and delivered on timelines. Provides medical writing strategy across clinical development and post-marketing lifecycle management, including process improvement.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety documents (protocols/amendments, CSRs, IBs, CTD sections, briefing documents, other submission documents).
- Lead cross-functional collaboration to develop, review, and finalize high-quality documents.
- Manage document development timelines, review cycles, and comment resolution.
- Interpret and summarize complex clinical/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.
Qualifications:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required.
- 7+ years in medical/regulatory writing, document management/publishing/operations in biotech/pharma/CRO.
- Demonstrated leadership authoring complex clinical/regulatory documents; strong drug development and global regulatory knowledge.
Preferred:
- Advanced degree (MS, PharmD, PhD).
Skills/Requirements:
- Expert scientific writing/editing/communication with strong attention to detail and quality.
- Proficiency: Microsoft Office, Veeva, electronic document management systems.
- Strong project management/independent judgment; cross-functional collaboration.
- Ability to travel up to 10%; onsite in San Diego required (not 100% remote).
Benefits:
- Premium health, life insurance, disability, retirement match, generous paid time off, wellness/employee support.
Compensation:
- Target base pay range: $132,000–$172,000.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.