Manager, Medical Writing Operations
Travere Therapeutics
August 30, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
- The Manager, Medical Writing Operations leads document specialist support across the Medical Writing function and authors/co-ordinates 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 a subject matter expert for Microsoft Word, document formatting, style management, templates, and document production best practices.
- Perform advanced document formatting/publishing (tables, figures, references, cross-references, automated numbering, TOC generation, document quality control).
- Manage document timelines, review cycles, and comment resolution.
- Develop/maintain/improve standardized templates, style guides, macros, and formatting tools.
- Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and others to ensure submission-ready documents.
- 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, and applicable guidance.
- Lead continuous improvement in document quality and operational excellence.
- Provide guidance/training on standards, templates, formatting, and best practices.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field (equivalent experience considered).
- MS/PhD/PharmD preferred.
- 6+ years in medical writing/regulatory writing/document management/medical writing operations (biotech/pharma/CRO).
- Experience authoring/coordinating clinical and regulatory documents for drug development and submissions.
Skills/Experience:
- Advanced Microsoft Word (styles, templates, section management, automated numbering, cross-references, TOC, doc comparison, large-document management).
- Experience with StartingPoint/TransCelerate and PerfectIt/Litera preferred.
- Experience with Veeva Vault/electronic document management and regulatory workflows.
- Publishing tools (Adobe Acrobat, Pragmatic SPL Validator) preferred.
- Expert writing/editing/quality review; strong attention to detail.
- Knowledge of FDA/EMA/ICH/global regulatory requirements.
- Strong project management, communication, and continuous-improvement mindset.
- Ability to travel up to 10%.
Benefits:
- Benefits include premium health, financial, work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
- The Manager, Medical Writing Operations leads document specialist support across the Medical Writing function and authors/co-ordinates 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 a subject matter expert for Microsoft Word, document formatting, style management, templates, and document production best practices.
- Perform advanced document formatting/publishing (tables, figures, references, cross-references, automated numbering, TOC generation, document quality control).
- Manage document timelines, review cycles, and comment resolution.
- Develop/maintain/improve standardized templates, style guides, macros, and formatting tools.
- Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and others to ensure submission-ready documents.
- 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, and applicable guidance.
- Lead continuous improvement in document quality and operational excellence.
- Provide guidance/training on standards, templates, formatting, and best practices.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field (equivalent experience considered).
- MS/PhD/PharmD preferred.
- 6+ years in medical writing/regulatory writing/document management/medical writing operations (biotech/pharma/CRO).
- Experience authoring/coordinating clinical and regulatory documents for drug development and submissions.
Skills/Experience:
- Advanced Microsoft Word (styles, templates, section management, automated numbering, cross-references, TOC, doc comparison, large-document management).
- Experience with StartingPoint/TransCelerate and PerfectIt/Litera preferred.
- Experience with Veeva Vault/electronic document management and regulatory workflows.
- Publishing tools (Adobe Acrobat, Pragmatic SPL Validator) preferred.
- Expert writing/editing/quality review; strong attention to detail.
- Knowledge of FDA/EMA/ICH/global regulatory requirements.
- Strong project management, communication, and continuous-improvement mindset.
- Ability to travel up to 10%.
Benefits:
- Benefits include premium health, financial, work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.