Manager, Medical Writing Operations

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.

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.

Education/Experience Requirements

• Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required.
• 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 Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• 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 with authoring tools and templates (eg, StartingPoint, TransCelerate) and reviewing tools (eg, PerfectIt, Litera) preferred.
• Experience with Veeva Vault, electronic document management systems, and regulatory document workflows.
• Experience with publishing tools (eg, Adobe Acrobat, Pragmatic SPL Validator) preferred.
• Expert scientific writing, editing, and document quality review skills with exceptional attention to detail.
• Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements governing clinical and regulatory documentation.
• Strong project management and organizational skills, with the ability to manage multiple priorities and competing deadlines.
• Excellent interpersonal, verbal, and written communication skills, with the ability to collaborate effectively across multidisciplinary teams.
• Demonstrated success identifying, leading, and implementing operational improvements that enhance efficiency and document quality.
• Ability to adapt to changing priorities and evolving project needs within a dynamic development environment.
• Ability to travel up to 10% domestic and internationally.