Senior Medical Writer - Remote (CERs & Submissions)

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

Benefits offered by this job

Benefits program

Growth opportunities

Career development

Job summary

Dexcom is seeking a Clinical Medical Writer to lead the creation and maintenance of clinical study reports and regulatory documents for global submissions. You will collaborate with Clinical Science, Biostatistics, Regulatory Affairs, and Quality to ensure accuracy and compliance across the product lifecycle.

The role requires strong scientific judgment, excellent writing skills, and experience with documentation standards such as EU MDR, ISO 14155, and FDA guidance.

Qualifications

• Bachelor’s degree and 5–8 years of related experience in the medical device, biotech, or pharmaceutical space.
• Experience independently authoring complex clinical and regulatory documents, notably clinical study reports and CERs.
• Ability to translate data into clear scientific narratives for regulators and cross-functional teams.

Responsibilities

• Lead planning, authoring, review, finalization, and lifecycle maintenance of clinical study reports.
• Author and maintain CEPs, CERs, PMCF plans and related evaluation reports.
• Design and conduct systematic and targeted literature searches with traceable outputs.

Skills

Clinical writing

Regulatory submissions

Education

Bachelor's degree

Tools

Microsoft Word

EndNote

DistillerSR

Cloud PLM

Jama

Smartsheet

Jira

Job description

Dexcom is seeking a Clinical Medical Writer to lead the creation and maintenance of clinical study reports and regulatory documents for global submissions. You will collaborate with Clinical Science, Biostatistics, Regulatory Affairs, and Quality to ensure accuracy and compliance across the product lifecycle.

The role requires strong scientific judgment, excellent writing skills, and experience with documentation standards such as EU MDR, ISO 14155, and FDA guidance.