Sr Medical Writer

Meet the team

The Clinical Medical Writing team is part of Dexcom's Clinical organization and partners across Clinical Affairs, Biostatistics, Data Science, Regulatory Affairs, Quality, Medical Affairs, and Research and Development to translate clinical evidence into clear, accurate, and submission-ready documentation. In this role, you will lead the authorship and lifecycle maintenance of clinical study reports, clinical evaluation reports, and other clinical deliverables that communicate study results and support global regulatory submissions.

Where you come in

• Lead the planning, authoring, review, finalization, and lifecycle maintenance of clinical study reports that accurately document clinical study methods, analyses, results, conclusions, and limitations.
• Author and maintain clinical evaluation plans (CEPs), clinical evaluation reports (CERs), post-market clinical follow-up (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, responses to FDA and other regulatory-authority questions, 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 other subject-matter experts to ensure documents are scientifically accurate, internally consistent, traceable, and aligned with approved source information.
• Interpret clinical study data, statistical outputs, tables, listings, figures, protocols, and analysis plans and translate complex information into clear, concise, and audience-appropriate scientific narratives.
• Manage document timelines, authoring plans, review cycles, comment resolution, approvals, and version control while identifying and communicating risks to delivery.
• Support inspection- and audit-ready documentation practices and contribute to medical writing procedures, templates, style standards, document-quality checks, and continuous process improvement.
• Apply relevant global medical-device requirements and guidance to assigned deliverables, including EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155, applicable U.S. FDA requirements and guidance, Good Clinical Practice, and other regional regulatory expectations.

What makes you successful

• 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 to evaluate source information, identify inconsistencies or evidence gaps, and work with subject-matter experts to reach clear, well-supported conclusions.
• Ability to write with clarity, precision, consistency, and appropriate context and tailor technical content for regulators, clinicians, scientists, and cross-functional stakeholders.
• Skilled at leading cross-functional document teams, facilitating review and comment resolution, managing multiple priorities, and delivering high-quality work to established timelines in a matrixed organization.
• Strong working knowledge of Microsoft Word and experience using EndNote, DistillerSR, Cloud PLM, Jama, Smartsheet, and Jira, or comparable reference-management, systematic-literature-review, electronic document-management, requirements-management, and project-management systems.
• Experience with continuous glucose monitoring, diabetes, digital health, or other regulated medical-device technologies is preferred.
• Working knowledge of 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 and Education Requirements

Typically requires a Bachelor's degree and a minimum 5 - 8 years of related experience.