Senior Medical Writer
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Job Description
Senior medical writer leading clinical study reports, evaluations, and regulatory documentation for Dexcom’s continuous glucose monitoring technology. Collaborating across clinical and regulatory teams.
Responsibilities:
- 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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