Manager, Medical Writing Operations
Travere Therapeutics
June 27, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
Manager, Medical Writing Operations leads document specialist support across Medical Writing and authors/co-ordinates regulatory, clinical, and safety documents to ensure deliverables are submission-ready, conformant with in-house style, scientifically accurate, and compliant with regulatory requirements.
Responsibilities:
- Serve as SME for Microsoft Word, document formatting, style management, templates, and production best practices.
- Perform advanced formatting/publishing (tables/figures, references, cross-references, automated numbering, TOC, and QC).
- Manage timelines, review cycles, and comment resolution.
- Develop/maintain standardized templates, style guides, macros, and formatting tools.
- Partner cross-functionally (Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance) to ensure compliance.
- Author/coordinate protocols/amendments, CSRs, investigator brochures, CTD components, and other submission documents.
- Maintain expertise in FDA/EMA/ICH guidance; lead continuous improvement.
- Guide/train authors on standards, templates, formatting, and best practices.
Qualifications/Requirements:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field required (equivalencies considered).
- 6+ years relevant experience in medical/regulatory writing, document management/publishing, or medical writing operations in biotech/pharma/CRO.
- Experience authoring and/or coordinating clinical and regulatory documents for drug development.
- Advanced document production/template management skills; working knowledge of drug development and global regulatory requirements.
Preferred Skills/Experience:
- MS/PharmD/PhD; familiarity with StartingPoint/TransCelerate; PerfectIt/Litera; Veeva Vault/e-DMS; Adobe Acrobat/Pragmatic SPL Validator.
Benefits:
- Premium health and work-life/well-being offerings, life insurance, disability, retirement match, and generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.
Manager, Medical Writing Operations leads document specialist support across Medical Writing and authors/co-ordinates regulatory, clinical, and safety documents to ensure deliverables are submission-ready, conformant with in-house style, scientifically accurate, and compliant with regulatory requirements.
Responsibilities:
- Serve as SME for Microsoft Word, document formatting, style management, templates, and production best practices.
- Perform advanced formatting/publishing (tables/figures, references, cross-references, automated numbering, TOC, and QC).
- Manage timelines, review cycles, and comment resolution.
- Develop/maintain standardized templates, style guides, macros, and formatting tools.
- Partner cross-functionally (Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance) to ensure compliance.
- Author/coordinate protocols/amendments, CSRs, investigator brochures, CTD components, and other submission documents.
- Maintain expertise in FDA/EMA/ICH guidance; lead continuous improvement.
- Guide/train authors on standards, templates, formatting, and best practices.
Qualifications/Requirements:
- Bachelor’s degree in Life Sciences/Medical/Health Sciences/Technical Writing or related field required (equivalencies considered).
- 6+ years relevant experience in medical/regulatory writing, document management/publishing, or medical writing operations in biotech/pharma/CRO.
- Experience authoring and/or coordinating clinical and regulatory documents for drug development.
- Advanced document production/template management skills; working knowledge of drug development and global regulatory requirements.
Preferred Skills/Experience:
- MS/PharmD/PhD; familiarity with StartingPoint/TransCelerate; PerfectIt/Litera; Veeva Vault/e-DMS; Adobe Acrobat/Pragmatic SPL Validator.
Benefits:
- Premium health and work-life/well-being offerings, life insurance, disability, retirement match, and generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.