Manager, Medical Writing Operations
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
Manager, Medical Writing Operations leads document specialist support across Medical Writing and authors/coordinating regulatory, clinical, and safety documents. Ensures deliverables are conformant with in-house style, scientifically accurate, compliant, and submission ready.
Responsibilities:
- Serve as SME for Microsoft Word, document formatting, style management, templates, and document production best practices.
- Perform advanced formatting/publishing (tables, figures, references, cross-references, automated numbering, TOC generation, quality control).
- Manage timelines, review cycles, and comment resolution to meet deadlines.
- Develop/maintain/improve templates, style guides, macros, and formatting tools.
- Partner cross-functionally (Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance) to ensure submission-ready documents.
- Author/coordinate protocols, amendments, CSRs, investigator brochures, CTD components, and other submission documents.
- Ensure accuracy/consistency/compliance; maintain expertise in FDA/EMA/ICH guidance.
- Lead continuous improvement; provide guidance/training; other assigned duties.
Education/Experience (Required):
- Bachelor’s degree in Life Sciences/Medical-Health Sciences/Technical Writing (or related).
- 6+ years in medical/regulatory writing, document management/operations; experience authoring/coordinating clinical & regulatory documents.
- Demonstrated expertise in document production and advanced MS Word.
Preferred Skills/Experience:
- MS/PharmD/PhD.
- Experience with StartingPoint/TransCelerate, PerfectIt/Litera; Veeva Vault and electronic document workflows; Adobe Acrobat/Pragmatic SPL Validator.
- Strong project management, communication, and operational improvement; travel up to 10%; not 100% remote (onsite/face-to-face in San Diego).
Benefits (as stated):
- Premium health, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
Application instruction:
- Applications accepted on an ongoing basis until selected.
Manager, Medical Writing Operations leads document specialist support across Medical Writing and authors/coordinating regulatory, clinical, and safety documents. Ensures deliverables are conformant with in-house style, scientifically accurate, compliant, and submission ready.
Responsibilities:
- Serve as SME for Microsoft Word, document formatting, style management, templates, and document production best practices.
- Perform advanced formatting/publishing (tables, figures, references, cross-references, automated numbering, TOC generation, quality control).
- Manage timelines, review cycles, and comment resolution to meet deadlines.
- Develop/maintain/improve templates, style guides, macros, and formatting tools.
- Partner cross-functionally (Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance) to ensure submission-ready documents.
- Author/coordinate protocols, amendments, CSRs, investigator brochures, CTD components, and other submission documents.
- Ensure accuracy/consistency/compliance; maintain expertise in FDA/EMA/ICH guidance.
- Lead continuous improvement; provide guidance/training; other assigned duties.
Education/Experience (Required):
- Bachelor’s degree in Life Sciences/Medical-Health Sciences/Technical Writing (or related).
- 6+ years in medical/regulatory writing, document management/operations; experience authoring/coordinating clinical & regulatory documents.
- Demonstrated expertise in document production and advanced MS Word.
Preferred Skills/Experience:
- MS/PharmD/PhD.
- Experience with StartingPoint/TransCelerate, PerfectIt/Litera; Veeva Vault and electronic document workflows; Adobe Acrobat/Pragmatic SPL Validator.
- Strong project management, communication, and operational improvement; travel up to 10%; not 100% remote (onsite/face-to-face in San Diego).
Benefits (as stated):
- Premium health, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
Application instruction:
- Applications accepted on an ongoing basis until selected.