Senior Medical Writer - Regulatory & Clinical Reports

Dexcom, Inc.; United States; Hybrid; USD 101,000 - 168,000; Full time

Benefits offered by this job

Full benefits program

Growth opportunities

Career development

Job summary

Dexcom, Inc. seeks a Sr Medical Writer to lead the authorship and lifecycle management of clinical study reports, CERs, CEPs and PMCF plans for global regulatory submissions.

You will collaborate with Clinical Science, Biostatistics, Regulatory Affairs, and Medical Affairs to ensure accuracy, traceability, and regulatory readiness of all deliverables. You will translate complex study data into concise scientific narratives, design literature searches, and drive timelines, version control, and

Qualifications

• Bachelor's degree in a scientific field and 5–8 years of related experience.
• Experience authoring clinical/regulatory documents for medical devices.
• Strong written and verbal communication skills.

Responsibilities

• Lead planning, authoring, review, and lifecycle maintenance of clinical study reports.
• Author CEPs, CERs, PMCF plans and evaluation deliverables for regulatory submissions.
• Design and execute literature searches with traceable outputs.
• Collaborate with Clinical Science, Biostatistics, Regulatory Affairs and Medical Affairs to ensure accuracy and alignment.

Skills

Clinical writing

Regulatory knowledge

Scientific judgment

Cross-functional collaboration

Education

Bachelor's degree

Tools

EndNote

DistillerSR

Cloud PLM

Jama

Smartsheet

Jira

Job description

Dexcom, Inc. seeks a Sr Medical Writer to lead the authorship and lifecycle management of clinical study reports, CERs, CEPs and PMCF plans for global regulatory submissions.

You will collaborate with Clinical Science, Biostatistics, Regulatory Affairs, and Medical Affairs to ensure accuracy, traceability, and regulatory readiness of all deliverables. You will translate complex study data into concise scientific narratives, design literature searches, and drive timelines, version control, and