Manager, Medical Writing Operations

Responsibilities

• 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.
• Ensure scientific accuracy, consistency, and compliance of documents with company standards and applicable regulatory requirements.
• Maintain expertise in FDA, EMA, ICH, and other applicable regulatory guidance related to document preparation and submissions.
• Lead continuous improvement initiatives focused on document quality, process optimization, and operational excellence.
• Provide guidance and training to document authors and cross-functional teams regarding document standards, templates, formatting requirements, and best practices.
• Additional duties assigned as needed.
• Education/Experience Requirements:
• Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required. Equivalent combination of education and applicable job experience may be considered.
• Advanced degree (MS, PharmD, PhD) preferred but not 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.
• Experience authoring and/or coordinating clinical and regulatory documents supporting drug development programs and regulatory submissions.
• Demonstrated expertise in document production, template management, and advanced Microsoft Word functionality.
• Working knowledge of drug development processes and applicable global regulatory requirements.
• Additional Skills/Experience/Requirements:
• The ideal candidate will embody

Benefits

Additional Information

Department: 107050 Medical Writing Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients . Position Summary: The Manager, Medical Writing Operations is responsible for leading document specialist support across the Medical Writing function and for authoring and coordinating regulatory, clinical, and safety documents. This position combines medical writing expertise with advanced document production and template management capabilities, serving as a functional subject matter expert resource for writers on complex document formatting, template development, and document quality standards while ensuring deliverables are conformant with in-house style, scientifically accurate, compliant with regulatory requirements, and submission ready. In addition to supporting the development of regulatory and clinical documents, this position serves as a subject matter expert for document formatting, template development, document quality standards, in-house style guides, and electronic document management systems. The Manager, Medical Writing Operations partners with cross-functional teams to manage and optimize document creation processes, improve efficiencies, and ensure submission-ready deliverables across all phases of product development.

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