Talent.com
Dexcom is hiring : Sr Medical Affairs Specialist - Regulatory Writing and Scienti

Dexcom is hiring : Sr Medical Affairs Specialist - Regulatory Writing and Scienti

MediabistroSan Diego, CA, United States
job_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

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

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Is Hiring Sr Medical • San Diego, CA, United States