[Hiring] Senior Medical Writer @Dexcom

Role Description

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. This is an opportunity to help shape high-quality clinical documentation for innovative continuous glucose monitoring technologies while working with cross-functional teams throughout the product lifecycle.

• You will lead the planning, authoring, review, finalization, and lifecycle maintenance of clinical study reports that accurately document clinical study methods, analyses, results, conclusions, and limitations.
• You will 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, incorporating clinical investigation data, published literature, post-market information, risk-management inputs, and product documentation, as applicable.
• You will design, document, execute, and maintain systematic and targeted literature searches, including search strategies, screening criteria, evidence tables, and traceable outputs supporting CEPs, CERs, PMCF activities, regulatory submissions, and publications.
• You will 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 needed for global regulatory submissions and interactions.
• You will 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.
• You will 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.
• You will manage document timelines, authoring plans, review cycles, comment resolution, approvals, and version control while identifying and communicating risks to delivery.
• You will support inspection- and audit-ready documentation practices and contribute to medical writing procedures, templates, style standards, document-quality checks, and continuous process improvement.
• You will apply relevant global medical-device requirements and guidance to assigned deliverables, including 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 other regional regulatory expectations.

Qualifications

• You have 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.
• You understand 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.
• You bring strong scientific judgment and can evaluate source information, identify inconsistencies or evidence gaps, and work with subject-matter experts to reach clear, well-supported conclusions.
• You write with clarity, precision, consistency, and appropriate context and can tailor technical content for regulators, clinicians, scientists, and cross-functional stakeholders.
• You are 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.
• You have 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.
• You have experience with continuous glucose monitoring, diabetes, digital health, or other regulated medical-device technologies is preferred.
• You have 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.

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Experience and Education Requirements

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

Remote Workplace

• Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
• If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.