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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in authoring and managing complex clinical and regulatory documents, including clinical study reports and evaluation reports, while ensuring compliance with global medical-device regulations and Good Clinical Practice. Strong ability to collaborate across functions and lead document teams to deliver high-quality scientific narratives and documentation.
Highest-signal resume keywords
Clinical Study Report AuthoringClinical Evaluation Report AuthoringGood Clinical PracticeRegulation (EU) 2017/745Cross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Research MethodologyScientific InterpretationDocument ManagementStatistical Analysis PlansRisk Management DocumentationClinical Study Protocol DevelopmentLiterature Search ExecutionEvidence Table CreationRegulatory SubmissionsDocument Quality Checks
Soft Skills
Strong Scientific JudgmentClear Scientific WritingComment ResolutionTime ManagementFacilitation Skills
Tools & Technologies
Microsoft WordEndNoteDistillerSRCloud PLMJamaSmartsheetJira
Industry Keywords
Medical DeviceBiotechnologyPharmaceuticalContinuous Glucose MonitoringDigital HealthEU MDRMEDDEV 2.7/1 Rev. 4ISO 14155U.S. FDA RequirementsClinical Evaluation
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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