Senior Manager, Medical Writing
Travere Therapeutics
August 31, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Clinical Research and Development
Position Summary:
Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents (protocols and amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission documents). Provides regulatory writing strategy and cross-functional leadership to ensure documents are scientifically accurate, compliant with applicable requirements, and delivered on time. Leads process improvements and advances medical writing standards and best practices across the clinical development and post-marketing lifecycle.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety documents ensuring accuracy and compliance.
- Lead cross-functional collaboration to develop, review, and finalize submission-ready documents.
- Manage timelines, review cycles, and comment resolution to meet milestones.
- Interpret and summarize complex clinical/scientific data into clear, accurate 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 and products.
- Additional duties as assigned.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field (equivalent experience/education considered).
- Advanced degree (MS, PharmD, PhD) preferred.
- 7+ years medical/regulatory writing or related experience in biotech/pharma/CRO.
- Leadership experience authoring complex clinical/regulatory documents.
- Strong knowledge of global drug development and regulatory requirements.
Additional Skills/Requirements:
- Expert scientific writing/editing/communication; strong attention to detail and quality.
- Proficiency with Microsoft Office, Veeva, and electronic document management systems.
- Strong project management; ability to manage multiple priorities.
- Ability to work independently and collaborate cross-functionally.
- Excellent verbal/written communication to technical and non-technical audiences.
- Adaptability to changing priorities.
- Travel up to 10%.
- Not expected to be 100% remote; must be able to perform face-to-face work/onsite in San Diego.
Benefits:
- Premium health, financial, work-life/well-being; wellness/employee support; 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 selected for the position.
Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents (protocols and amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission documents). Provides regulatory writing strategy and cross-functional leadership to ensure documents are scientifically accurate, compliant with applicable requirements, and delivered on time. Leads process improvements and advances medical writing standards and best practices across the clinical development and post-marketing lifecycle.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety documents ensuring accuracy and compliance.
- Lead cross-functional collaboration to develop, review, and finalize submission-ready documents.
- Manage timelines, review cycles, and comment resolution to meet milestones.
- Interpret and summarize complex clinical/scientific data into clear, accurate 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 and products.
- Additional duties as assigned.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field (equivalent experience/education considered).
- Advanced degree (MS, PharmD, PhD) preferred.
- 7+ years medical/regulatory writing or related experience in biotech/pharma/CRO.
- Leadership experience authoring complex clinical/regulatory documents.
- Strong knowledge of global drug development and regulatory requirements.
Additional Skills/Requirements:
- Expert scientific writing/editing/communication; strong attention to detail and quality.
- Proficiency with Microsoft Office, Veeva, and electronic document management systems.
- Strong project management; ability to manage multiple priorities.
- Ability to work independently and collaborate cross-functionally.
- Excellent verbal/written communication to technical and non-technical audiences.
- Adaptability to changing priorities.
- Travel up to 10%.
- Not expected to be 100% remote; must be able to perform face-to-face work/onsite in San Diego.
Benefits:
- Premium health, financial, work-life/well-being; wellness/employee support; 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 selected for the position.