Manager, Medical Writing Operations
Travere Therapeutics
June 27, 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/coordinates 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, 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 to ensure documents are submission-ready and meet regulatory publishing requirements.
- Author and 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; guide and train authors/teams on standards and best practices.
Education/Experience Requirements:
- Bachelor’s in Life Sciences/Medical/Health Sciences/Technical Writing or related (equivalent considered).
- 6+ years relevant experience in medical/regulatory writing, document management/publishing/operations in pharma/biotech/CRO.
- Experience authoring/coordination of clinical and regulatory documents for drug development.
Additional Skills/Requirements (selected):
- Advanced Microsoft Word expertise; document production/template management.
- Knowledge of global drug development processes and regulatory requirements.
- Preferred: StartingPoint/TransCelerate; PerfectIt/Litera; Veeva Vault/e-DMS; Adobe Acrobat/Pragmatic SPL Validator.
- Strong project management, communication, quality, and cross-functional collaboration; ability to travel up to 10%.
- Onsite/face-to-face required in San Diego; not 100% remote.
Benefits/Compensation (as stated):
- Premium health and well-being offerings, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $116,000–$151,000.
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/coordinates 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, 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 to ensure documents are submission-ready and meet regulatory publishing requirements.
- Author and 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; guide and train authors/teams on standards and best practices.
Education/Experience Requirements:
- Bachelor’s in Life Sciences/Medical/Health Sciences/Technical Writing or related (equivalent considered).
- 6+ years relevant experience in medical/regulatory writing, document management/publishing/operations in pharma/biotech/CRO.
- Experience authoring/coordination of clinical and regulatory documents for drug development.
Additional Skills/Requirements (selected):
- Advanced Microsoft Word expertise; document production/template management.
- Knowledge of global drug development processes and regulatory requirements.
- Preferred: StartingPoint/TransCelerate; PerfectIt/Litera; Veeva Vault/e-DMS; Adobe Acrobat/Pragmatic SPL Validator.
- Strong project management, communication, quality, and cross-functional collaboration; ability to travel up to 10%.
- Onsite/face-to-face required in San Diego; not 100% remote.
Benefits/Compensation (as stated):
- Premium health and well-being offerings, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $116,000–$151,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.