Travere Therapeutics is a biotechnology company on a mission to identify, develop, and deliver life-changing therapies to people living with rare diseases. As a
Manager, Medical Writing Operations
Location
California
Posted
4 days ago
Salary
$116K - $151K / year
Seniority
Senior
Job Description
Manager, Medical Writing Operations
Travere Therapeutics
• Serve as a subject matter expert for Microsoft Word, document formatting, style management, templates, and document production best practices • Perform advanced document formatting and publishing activities, including management of complex tables, figures, references, cross-references, automated numbering, table of contents generation, and document quality control • Manage document development timelines, review cycles, and comment resolution activities to ensure high-quality deliverables are completed on schedule • Develop, maintain, and improve standardized document templates, style guides, macros, and formatting tools to support efficient document development and regulatory submissions • Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and other functions to ensure documents are submission-ready and comply with regulatory publishing requirements • Author and coordinate the preparation of clinical, regulatory, and safety documents, including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), CTD components, and other submission-related documents.
Job Requirements
- Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required
- 6+ years of relevant experience in medical writing, regulatory writing, document management, publishing, or medical writing operations within the biotechnology, pharmaceutical, CRO, or related healthcare industry environment
- Advanced proficiency in Microsoft Word, including styles, templates, section management, automated numbering, cross-references, tables of contents, document comparison tools, and large-document management
- Experience authoring and/or coordinating clinical and regulatory documents supporting drug development programs and regulatory submissions.
- Working knowledge of drug development processes and applicable global regulatory requirements.
Benefits
- premium health
- financial
- work-life
- well-being offerings for eligible employees and dependents
- wellness and employee support programs
- life insurance
- disability
- retirement plans with employer match
- generous paid time off
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