Senior Manager, Medical Writing

Responsibilities

• Author and coordinate the preparation of regulatory, clinical, and safety documents, ensuring scientific accuracy, consistency, and compliance with regulatory requirements and company standards.
• Lead cross-functional collaborations with stakeholders to develop, review, and finalize high-quality documents in support of clinical development programs and regulatory submissions.
• Manage document development timelines, review cycles, and comment resolution activities to ensure timely delivery of project milestones.
• Interpret, analyze, and summarize complex clinical and scientific data into clear, accurate, and submission-ready content.
• Ensure adherence to applicable FDA, EMA, ICH, and other relevant regulatory guidelines and industry standards.
• Proactively contribute and lead development and continuous improvements of medical writing processes, capabilities, templates, style guides, and standard operating procedures through innovation and adoption of industry best practices and drive alignment across programs.
• Develop and maintain expertise in assigned therapeutic areas and products to support scientific and regulatory communication needs.
• 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.
• 7+ 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.
• Demonstrated leadership experience authoring complex clinical and regulatory documents supporting drug development programs and regulatory submissions.
• Strong working knowledge of drug development processes and applicable global regulatory requirements.
• Exercise a high degree of independent judgment in determining approaches, priorities, and solutions for complex scientific and regulatory challenges.
• Additional Skills/Experience/Requirements:
• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Expert scientific writing, editing, and communication skills, with exceptional attention to detail and commitment to quality.
• Demonstrated experience authoring clinical, regulatory, and scientific documents within the biotechnology or pharmaceutical industry.
• Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to clinical development and regulatory submissions.
• Proficiency with Microsoft Office applications, Veeva platforms, and electronic document management systems.
• Strong project management and organizational skills, with the ability to manage multipl

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 Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents, including but not limited to protocols and protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), Common Technical Document (CTD) sections, briefing documents, and other submission-related documents. This position is the subject matter expert in regulatory writing and partners with cross-functional teams to provide strategic guidance and leadership ensuring documents are scientifically accurate, compliant with applicable regulatory requirements, and delivered according to project timelines. In addition, this position provides medical writing strategy and leadership across all phases of clinical development and post-marketing lifecycle management anticipating and leading process improvements and the advancement of medical writing standards and best practices.

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