Senior Manager, Medical Writing

Department: 107050. Location: San Diego, USA - Remote. Position Summary The Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents, including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), Common Technical Document (CTD) sections, briefing documents, and other submission‑related documents. The role serves as 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 regulatory requirements, and delivered on schedule. The Senior Manager also leads medical writing strategy and continuous improvement across all phases of clinical development and post‑marketing lifecycle management. 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 supporting 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 to 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. Develop and maintain expertise in assigned therapeutic areas and products to support scientific and regulatory communication needs. Additional duties assigned as needed. Travel up to 10% domestically and internationally. Perform essential face‑to‑face work with colleagues and/or onsite in San Diego; remote work is not 100% possible. Education & Experience 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 Expert scientific writing, editing, and communication skills, with exceptional attention to detail and commitment to quality. 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, Veeva platforms, and electronic document management systems. Strong project management and organizational skills, ability to manage multiple priorities and deliver high‑quality work within established timelines. Ability to work independently while collaborating effectively with cross‑functional teams and stakeholders at all levels. Excellent interpersonal, verbal, and written communication skills, clarity for both technical and non‑technical audiences. Demonstrated ability to adapt to changing priorities, evolving project requirements, and a dynamic development environment. Benefits Travere provides comprehensive total rewards offerings including premium health, financial, work‑life and well‑being programs, life insurance, disability coverage, retirement plans with employer match, and generous paid time off. Compensation includes a combination of base pay and short‑term incentive, as well as long‑term incentive (company stock). Target Base Pay Range: $132,000.00 – $172,000.00. EEO Statement Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. #J-18808-Ljbffr Travere Therapeutics