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Senior Manager, Medical Writing
Travere TherapeuticsSenior Manager overseeing regulatory and clinical document development at Travere Therapeutics. Leading cross-functional teams and ensuring compliance with regulatory standards.
Posted 6/27/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $132,000 - $172,000 per yearWebsite
Core Competencies
Role fitCore Competencies
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The ideal candidate must demonstrate expertise in medical writing and regulatory compliance, with a strong ability to lead cross-functional teams and manage complex document development processes. A commitment to quality and attention to detail is essential for producing submission-ready content that adheres to industry standards.
ATS Keywords
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Hard Skills
Medical WritingRegulatory WritingDocument ManagementScientific WritingEditingData AnalysisQuality AssuranceDrug Development ProcessesRegulatory SubmissionsClinical Document Preparation
Soft Skills
LeadershipCollaborationCommunicationAttention to DetailProblem-SolvingTime ManagementInterpersonal SkillsOrganizational SkillsCritical ThinkingAdaptability
Tools & Technologies
Microsoft OfficeVeeva PlatformsElectronic Document Management Systems
Industry Keywords
FDA GuidelinesEMA GuidelinesICH GuidelinesBiotechnologyPharmaceuticalCROHealthcare IndustryMedical Writing ProcessesStandard Operating ProceduresSubmission-Ready Content
About the role
Key responsibilities & impact- Author and coordinate the preparation of regulatory, clinical, and safety documents
- Lead cross-functional collaborations with stakeholders to develop, review, and finalize high-quality documents
- Manage document development timelines, review cycles, and comment resolution activities
- 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
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field 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
- Expert scientific writing, editing, and communication skills, with exceptional attention to detail and commitment to quality
- 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
Benefits
Comp & perks- Premium health, financial, work-life and well-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability
- Retirement plans with employer match
- Generous paid time off