Senior Medical Writer

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $100.7k - $167.9k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• Lead the planning, authoring, review, finalization, and lifecycle maintenance of clinical study reports • Author and maintain clinical evaluation plans, clinical evaluation reports, PMCF plans and evaluation reports, and supporting clinical evaluation deliverables • Design, document, execute, and maintain systematic and targeted literature searches, including search strategies, screening criteria, evidence tables, and traceable outputs • Develop and update clinical study protocols, protocol amendments, clinical summaries, benefit-risk documentation, regulatory-authority responses, notified-body responses, publications, and other clinical and scientific deliverables • Collaborate with Clinical Science, Clinical Program Management, Biostatistics, Data Science, Regulatory Affairs, Quality, Medical Affairs, and subject-matter experts • Interpret clinical study data, statistical outputs, tables, listings, figures, protocols, and analysis plans into clear scientific narratives • Manage document timelines, authoring plans, review cycles, comment resolution, approvals, and version control while communicating delivery risks • Support inspection- and audit-ready documentation practices • Contribute to medical writing procedures, templates, style standards, document-quality checks, and continuous process improvement • Apply global medical-device requirements and guidance to assigned deliverables and regulatory submissions

🎯 Requirements

• Bachelor's degree • 5–8 years of related experience • Demonstrated experience independently authoring and leading complex clinical and regulatory documents, particularly clinical study reports and clinical evaluation reports, within the medical device, biotechnology, or pharmaceutical industry • Understanding of clinical research methodology, medical-device development, Good Clinical Practice, scientific interpretation, and the relationship among protocols, statistical analysis plans, clinical data, risk-management documentation, and regulatory submissions • Strong scientific judgment and ability to evaluate source information, identify inconsistencies or evidence gaps, and reach well-supported conclusions with subject-matter experts • Clear, precise, consistent scientific writing tailored to regulators, clinicians, scientists, and cross-functional stakeholders • Ability to lead cross-functional document teams, facilitate review and comment resolution, manage multiple priorities, and deliver to established timelines in a matrixed organization • Strong working knowledge of Microsoft Word • Experience using EndNote, DistillerSR, Cloud PLM, Jama, Smartsheet, and Jira, or comparable systems • Working knowledge of Regulation (EU) 2017/745 (EU MDR), MEDDEV 2.7/1 Rev. 4, ISO 14155, applicable U.S. FDA requirements and guidance, Good Clinical Practice, and global clinical evaluation and regulatory-documentation expectations • Experience with continuous glucose monitoring, diabetes, digital health, or other regulated medical-device technologies is preferred • 5–15% travel required

🏖️ Benefits

• A full and comprehensive benefits program • Growth opportunities on a global scale • Career development through in-house learning programs and/or qualified tuition reimbursement • Home-office remote workplace • Hybrid working environment may be available for employees within commuting distance of a Dexcom site • Flex workplace option • Equal opportunity employment and reasonable accommodations

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