Overview Sr Medical Affairs Specialist – Regulatory Writing and Scientific Communications. Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). We are a globally driven team focused on improving health outcomes by delivering personalized, actionable insights and advancing health technology. Dexcom is committed to empowering people to take control of their health and to solving important health challenges.
Dexcom Medical Affairs is seeking candidates for the role Senior Medical Affairs Specialist – Scientific Communications and Regulatory Writing. In this role you will own the Medical Affairs planning, authorship, and lifecycle maintenance of Clinical Evaluation Reports (CERs) and related documentation, and design and manage compliant literature search strategies. You will also develop abstracts, posters, and manuscripts that communicate Dexcom evidence to external audiences in alignment with GPP / ICMJE guidance and internal publication processes. This is a great opportunity to shape the function and collaborate with outstanding colleagues.
Where You Come In You will lead the authoring and updates of CERs and supporting documents
You will define and execute literature search strategies in support of regulatory filings, including vendor management
You will partner with Regulatory Affairs to ensure alignment of all documentation with corporate objectives
You will manage project scope, schedule, risk / issue tracking, and stakeholder communication
You will write high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (e.g., GPP)
You will ensure timely feedback, review cycles, and adherence to deadlines for deliverables
You will assist with tracking for scientific communication-related activities
What Makes You Successful You have an advanced degree in a relevant scientific field
You have a minimum of 3–5 years of experience in regulatory / clinical / medical writing within medical devices, biotech, or pharma
You have strong knowledge of EU MDR / MEDDEV expectations for clinical evaluation reports
Previous experience in diabetes preferred
You have in-depth knowledge of industry regulations and guidelines governing publications and medical communications
You have strong project management skills with the ability to manage multiple high-priority projects simultaneously
You have excellent written and verbal communication skills
What You’ll Get A front row seat to life-changing CGM technology with the Dexcom warrior community
A comprehensive benefits program
Growth opportunities on a global scale
Access to career development through in-house learning programs and tuition reimbursement
An innovative, industry-leading organization committed to employees, customers, and communities
Travel Required 5–15%
Experience And Education Requirements Typically requires a Bachelor’s degree and 5–8 years of related experience
Remote Workplace Your location can be a home office; you are not required to live within commuting distance of a Dexcom site. If you reside within commuting distance, a hybrid option may be available. Flex workplace option may be discussed.
Please note : The information contained herein is not an all-inclusive list of duties or required skills. Management may assign or reassign duties at any time. Dexcom is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status or disability. For accessibility, contact Talent Acquisition at talentacquisition@dexcom.com.
Salary : $95,900.00 - $159,900.00
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Regulatory Specialist • San Diego, CA, United States