Senior Manager, Medical Writing

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.

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.

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.
• 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 multiple priorities and deliver high-quality work within established timelines.
• Able to work independently while collaborating effectively with cross-functional teams and stakeholders at all levels of the organization.
• Excellent interpersonal, verbal, and written communication skills, with the ability to communicate complex scientific information to both technical and non-technical audiences.
• Demonstrated ability to adapt to changing priorities, evolving project requirements, and a dynamic development environment.
• Ability to travel up to 10% domestically and internationally.