Senior Manager, Medical Writing
Travere Therapeutics
June 27, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary:
The Senior Manager, Medical Writing authors, manages, and leads development of regulatory, clinical, and safety documents (protocols/protocol amendments, CSRs, IBs, CTD sections, briefing documents, and other submission-related documents). Serves as a regulatory writing subject matter expert, partnering cross-functionally to ensure documents are scientifically accurate, compliant, and delivered on time. Provides medical writing strategy and leadership across clinical development and post-marketing lifecycle management.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety document preparation with accuracy and compliance.
- Lead cross-functional collaboration to develop, review, and finalize submission-ready documents.
- Manage development timelines, review cycles, and comment resolution.
- Interpret and summarize complex clinical/scientific data into clear submission content.
- Ensure adherence to FDA/EMA/ICH and relevant regulatory guidelines.
- Lead continuous improvements to medical writing processes, templates, SOPs, and best practices.
- Develop expertise in therapeutic areas/products to support scientific and regulatory communication.
Qualifications:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field required.
- 7+ years medical writing/regulatory writing/document management/publishing/operations in biotech/pharma/CRO.
- Demonstrated leadership authoring complex clinical/regulatory documents.
- Strong global regulatory requirements knowledge.
- Independent judgment for complex scientific/regulatory challenges.
Skills/Requirements:
- Expert scientific writing/editing/communication; strong attention to detail and quality.
- Knowledge of FDA/EMA/ICH guidance.
- Proficiency with Microsoft Office, Veeva, and electronic document management.
- Strong project management; can manage multiple priorities and collaborate cross-functionally.
- Travel up to 10%; onsite/face-to-face in San Diego (not 100% remote).
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.
The Senior Manager, Medical Writing authors, manages, and leads development of regulatory, clinical, and safety documents (protocols/protocol amendments, CSRs, IBs, CTD sections, briefing documents, and other submission-related documents). Serves as a regulatory writing subject matter expert, partnering cross-functionally to ensure documents are scientifically accurate, compliant, and delivered on time. Provides medical writing strategy and leadership across clinical development and post-marketing lifecycle management.
Responsibilities:
- Author and coordinate regulatory, clinical, and safety document preparation with accuracy and compliance.
- Lead cross-functional collaboration to develop, review, and finalize submission-ready documents.
- Manage development timelines, review cycles, and comment resolution.
- Interpret and summarize complex clinical/scientific data into clear submission content.
- Ensure adherence to FDA/EMA/ICH and relevant regulatory guidelines.
- Lead continuous improvements to medical writing processes, templates, SOPs, and best practices.
- Develop expertise in therapeutic areas/products to support scientific and regulatory communication.
Qualifications:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field required.
- 7+ years medical writing/regulatory writing/document management/publishing/operations in biotech/pharma/CRO.
- Demonstrated leadership authoring complex clinical/regulatory documents.
- Strong global regulatory requirements knowledge.
- Independent judgment for complex scientific/regulatory challenges.
Skills/Requirements:
- Expert scientific writing/editing/communication; strong attention to detail and quality.
- Knowledge of FDA/EMA/ICH guidance.
- Proficiency with Microsoft Office, Veeva, and electronic document management.
- Strong project management; can manage multiple priorities and collaborate cross-functionally.
- Travel up to 10%; onsite/face-to-face in San Diego (not 100% remote).
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.