Manager, Medical Writing Operations
Travere Therapeutics
August 30, 2026
On-site
San Diego Metropolitan Area
Operations
Position Summary:
The 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 with regulatory requirements, and submission-ready.
Responsibilities:
- Serve as SME for Microsoft Word, document formatting, style management, templates, and document production best practices.
- Perform advanced formatting/publishing (complex tables/figures/references, cross-references, automated numbering, TOC generation, document QC).
- Manage timelines, review cycles, and comment resolution to meet schedules.
- Develop/maintain/improve standardized templates, style guides, macros, and formatting tools.
- Partner cross-functionally (Medical Writing, Regulatory Ops, Clinical Development, Biometrics, Pharmacovigilance) to ensure submission-ready documents.
- Author/coordinate clinical/regulatory/safety documents (protocols, amendments, CSRs, IBs, CTD components, etc.).
- Ensure scientific accuracy, consistency, and compliance; maintain expertise in FDA/EMA/ICH guidance.
- Lead continuous improvement; provide guidance/training on standards and best practices.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Medical-Health Sciences/Technical Writing or related (or equivalent).
- Advanced degree preferred.
- 6+ years in medical/regulatory writing, document management, publishing, or medical writing operations (biotech/pharma/CRO).
- Experience authoring/coordinating clinical and regulatory documents for drug development.
- Demonstrated expertise in document production, template management, advanced MS Word.
- Working knowledge of drug development processes and global regulatory requirements.
Additional Skills/Requirements:
- Advanced MS Word (styles, templates, section management, numbering, cross-references, TOC, comparison, large-document management).
- Preferred: StartingPoint/TransCelerate; PerfectIt/Litera; Veeva Vault/eDMS; Adobe Acrobat/Pragmatic SPL Validator.
- Expert scientific writing/editing/QC; strong project management; communication and cross-functional collaboration.
- Travel up to 10%; role not expected to be 100% remote (onsite/face-to-face in San Diego required).
Benefits/Compensation:
- Target Base Pay Range: $116,000.00 - $151,000.00
- Benefits: premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement match, generous PTO.
Application instructions:
- Applications accepted on an ongoing basis until a candidate is selected for the position.
The 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 with regulatory requirements, and submission-ready.
Responsibilities:
- Serve as SME for Microsoft Word, document formatting, style management, templates, and document production best practices.
- Perform advanced formatting/publishing (complex tables/figures/references, cross-references, automated numbering, TOC generation, document QC).
- Manage timelines, review cycles, and comment resolution to meet schedules.
- Develop/maintain/improve standardized templates, style guides, macros, and formatting tools.
- Partner cross-functionally (Medical Writing, Regulatory Ops, Clinical Development, Biometrics, Pharmacovigilance) to ensure submission-ready documents.
- Author/coordinate clinical/regulatory/safety documents (protocols, amendments, CSRs, IBs, CTD components, etc.).
- Ensure scientific accuracy, consistency, and compliance; maintain expertise in FDA/EMA/ICH guidance.
- Lead continuous improvement; provide guidance/training on standards and best practices.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences/Medical-Health Sciences/Technical Writing or related (or equivalent).
- Advanced degree preferred.
- 6+ years in medical/regulatory writing, document management, publishing, or medical writing operations (biotech/pharma/CRO).
- Experience authoring/coordinating clinical and regulatory documents for drug development.
- Demonstrated expertise in document production, template management, advanced MS Word.
- Working knowledge of drug development processes and global regulatory requirements.
Additional Skills/Requirements:
- Advanced MS Word (styles, templates, section management, numbering, cross-references, TOC, comparison, large-document management).
- Preferred: StartingPoint/TransCelerate; PerfectIt/Litera; Veeva Vault/eDMS; Adobe Acrobat/Pragmatic SPL Validator.
- Expert scientific writing/editing/QC; strong project management; communication and cross-functional collaboration.
- Travel up to 10%; role not expected to be 100% remote (onsite/face-to-face in San Diego required).
Benefits/Compensation:
- Target Base Pay Range: $116,000.00 - $151,000.00
- Benefits: premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement match, generous PTO.
Application instructions:
- Applications accepted on an ongoing basis until a candidate is selected for the position.