Senior Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning, creation, review, finalization, and ongoing maintenance of clinical study reports.

• Draft and manage clinical evaluation plans, clinical evaluation reports, PMCF plans, evaluation reports, and other related clinical evaluation deliverables.

• Design, document, execute, and sustain systematic and targeted literature searches, including search strategies, screening criteria, evidence tables, and traceable outputs.

• Create and revise clinical study protocols, protocol amendments, clinical summaries, benefit-risk documentation, regulatory authority responses, notified body responses, publications, and other scientific and clinical deliverables.

• Collaborate with teams in Clinical Science, Clinical Program Management, Biostatistics, Data Science, Regulatory Affairs, Quality, Medical Affairs, and subject-matter experts.

• Analyze clinical study data, statistical outputs, tables, listings, figures, protocols, and analysis plans into coherent scientific narratives.

• Manage document timelines, authoring plans, review cycles, comment resolution, approvals, and version control while effectively communicating delivery risks.

• Assist in maintaining inspection- and audit-ready documentation practices.

• Contribute to medical writing procedures, templates, style standards, document quality checks, and ongoing process enhancements.

• Implement global medical device requirements and guidelines for assigned deliverables and regulatory submissions.

⛳️ Requirements

• Bachelor's degree.

• 5–8 years of relevant experience.

• Proven ability to independently author and lead complex clinical and regulatory documents, particularly clinical study reports and clinical evaluation reports, within the medical device, biotechnology, or pharmaceutical sectors.

• Familiarity with clinical research methodologies, medical device development, Good Clinical Practice, scientific interpretation, and the relationships among protocols, statistical analysis plans, clinical data, risk management documentation, and regulatory submissions.

• Strong scientific judgment and capacity to evaluate source information, detect inconsistencies or evidence gaps, and derive well-supported conclusions alongside subject-matter experts.

• Clear, precise, and 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 meet established timelines in a matrixed environment.

• Proficient in Microsoft Word.

• Experience with EndNote, DistillerSR, Cloud PLM, Jama, Smartsheet, and Jira, or similar systems.

• Working knowledge of Regulation (EU) 2017/745 (EU MDR), MEDDEV 2.7/1 Rev. 4, ISO 14155, relevant U.S. FDA requirements and guidance, Good Clinical Practice, and global clinical evaluation and regulatory documentation standards.

• Experience with continuous glucose monitoring, diabetes, digital health, or other regulated medical device technologies is preferred.

• 5–15% travel required.

🏝️ Benefits

• A comprehensive and extensive benefits program.

• Opportunities for growth on a global scale.

• Career development through in-house training programs and/or eligible tuition reimbursement.

• Remote workplace options available.

• Hybrid working arrangements may be possible for employees within commuting distance of a Dexcom location.

• Flexible workplace options.

• Commitment to equal opportunity employment and reasonable accommodations.