Manager, Medical Writing Operations
Travere Therapeutics
August 09, 2026
Remote friendly (United States)
United States
Operations
Position Summary:
The Manager, Medical Writing Operations leads document specialist support across Medical Writing and authors/co-ordinates regulatory, clinical, and safety documents. Serves as a functional subject matter expert for complex document formatting, template development, and document quality standards, ensuring deliverables are in-house style compliant, scientifically accurate, regulatory-compliant, and submission ready.
Responsibilities:
- Be a subject matter expert 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 quality control).
- Manage timelines, review cycles, and comment resolution to meet schedules.
- Develop/maintain standardized templates, style guides, macros, and formatting tools.
- Partner with cross-functional teams (Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, etc.) to ensure submission-ready documents.
- Author and coordinate clinical, regulatory, and safety documents (protocols/amendments, CSRs, investigator brochures, CTD components, etc.).
- Ensure scientific accuracy, consistency, and compliance; maintain expertise in FDA/EMA/ICH guidance.
- Lead continuous improvement; provide guidance/training on standards, templates, and best practices.
Education/Experience (Required):
- Bachelor’s degree in Life Sciences/Medical-Health Sciences/Technical Writing or related.
- 6+ years in medical writing/regulatory writing/document management/publishing/medical writing operations.
- Experience authoring and/or coordinating clinical and regulatory documents for drug development.
- Demonstrated advanced Microsoft Word/document production and template management expertise.
- Working knowledge of drug development processes and global regulatory requirements.
Preferences/Skills:
- Advanced degree (MS/PharmD/PhD).
- Experience with StartingPoint/TransCelerate, PerfectIt/Litera, Veeva Vault/e-DMS, and publishing tools (e.g., Acrobat, Pragmatic SPL Validator).
- Expert editing/quality review; strong project management/communication; ability to travel up to 10%.
Benefits (as stated):
- Premium health and other insurance, retirement with employer match, generous paid time off.
Compensation (as stated):
- Target base pay: $116,000–$151,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Manager, Medical Writing Operations leads document specialist support across Medical Writing and authors/co-ordinates regulatory, clinical, and safety documents. Serves as a functional subject matter expert for complex document formatting, template development, and document quality standards, ensuring deliverables are in-house style compliant, scientifically accurate, regulatory-compliant, and submission ready.
Responsibilities:
- Be a subject matter expert 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 quality control).
- Manage timelines, review cycles, and comment resolution to meet schedules.
- Develop/maintain standardized templates, style guides, macros, and formatting tools.
- Partner with cross-functional teams (Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, etc.) to ensure submission-ready documents.
- Author and coordinate clinical, regulatory, and safety documents (protocols/amendments, CSRs, investigator brochures, CTD components, etc.).
- Ensure scientific accuracy, consistency, and compliance; maintain expertise in FDA/EMA/ICH guidance.
- Lead continuous improvement; provide guidance/training on standards, templates, and best practices.
Education/Experience (Required):
- Bachelor’s degree in Life Sciences/Medical-Health Sciences/Technical Writing or related.
- 6+ years in medical writing/regulatory writing/document management/publishing/medical writing operations.
- Experience authoring and/or coordinating clinical and regulatory documents for drug development.
- Demonstrated advanced Microsoft Word/document production and template management expertise.
- Working knowledge of drug development processes and global regulatory requirements.
Preferences/Skills:
- Advanced degree (MS/PharmD/PhD).
- Experience with StartingPoint/TransCelerate, PerfectIt/Litera, Veeva Vault/e-DMS, and publishing tools (e.g., Acrobat, Pragmatic SPL Validator).
- Expert editing/quality review; strong project management/communication; ability to travel up to 10%.
Benefits (as stated):
- Premium health and other insurance, retirement with employer match, generous paid time off.
Compensation (as stated):
- Target base pay: $116,000–$151,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.