Senior Manager, Medical Writing
Travere Therapeutics
August 09, 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 development of regulatory, clinical, and safety documents (protocols/protocol amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission-related documents). Subject matter expert in regulatory writing; provides strategy and leadership 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 improvements and advancement of best practices.
Responsibilities:
- Author and coordinate regulatory/clinical/safety documents with accuracy and compliance.
- Lead cross-functional collaborations to develop, review, and finalize submission-ready documents.
- Manage document development timelines, review cycles, and comment resolution.
- Interpret and summarize complex clinical/scientific data for submission.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Lead continuous improvements to medical writing processes, templates, SOPs, and standards.
- Develop expertise in therapeutic areas/products to support scientific and regulatory communication.
Qualifications/Experience:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field (or equivalent).
- MS/PharmD/PhD preferred.
- 7+ years relevant medical/regulatory writing and document management in biotech/pharma/CRO.
- Leadership experience authoring complex clinical/regulatory documents.
- Strong working knowledge of drug development and global regulatory requirements.
Skills/Requirements:
- Expert writing/editing/communication; strong attention to detail and quality.
- Proficiency: Microsoft Office, Veeva, electronic document management.
- Project management/organizational skills; manage multiple priorities.
- Collaborate effectively across teams; communicate complex science to technical/non-technical audiences.
- Adapt to changing priorities; travel up to 10%.
- Onsite/face-to-face essential function in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being offerings; wellness/support programs; life insurance, disability, retirement match; generous paid time off.
Application Instructions:
- Apply on an ongoing basis until selected.
Senior Manager, Medical Writing responsible for authoring, managing, and leading development of regulatory, clinical, and safety documents (protocols/protocol amendments, CSRs, investigator brochures, CTD sections, briefing documents, and other submission-related documents). Subject matter expert in regulatory writing; provides strategy and leadership 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 improvements and advancement of best practices.
Responsibilities:
- Author and coordinate regulatory/clinical/safety documents with accuracy and compliance.
- Lead cross-functional collaborations to develop, review, and finalize submission-ready documents.
- Manage document development timelines, review cycles, and comment resolution.
- Interpret and summarize complex clinical/scientific data for submission.
- Ensure adherence to FDA, EMA, ICH, and other relevant regulatory guidelines.
- Lead continuous improvements to medical writing processes, templates, SOPs, and standards.
- Develop expertise in therapeutic areas/products to support scientific and regulatory communication.
Qualifications/Experience:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field (or equivalent).
- MS/PharmD/PhD preferred.
- 7+ years relevant medical/regulatory writing and document management in biotech/pharma/CRO.
- Leadership experience authoring complex clinical/regulatory documents.
- Strong working knowledge of drug development and global regulatory requirements.
Skills/Requirements:
- Expert writing/editing/communication; strong attention to detail and quality.
- Proficiency: Microsoft Office, Veeva, electronic document management.
- Project management/organizational skills; manage multiple priorities.
- Collaborate effectively across teams; communicate complex science to technical/non-technical audiences.
- Adapt to changing priorities; travel up to 10%.
- Onsite/face-to-face essential function in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being offerings; wellness/support programs; life insurance, disability, retirement match; generous paid time off.
Application Instructions:
- Apply on an ongoing basis until selected.