Sr Medical Affairs Specialist - Regulatory Writing and Scientific Communica at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

159900.0

Posted On

07 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Writing, Scientific Communications, Project Management, Clinical Evaluation Reports, Literature Search Strategies, Medical Writing, Diabetes Knowledge, EU MDR, Communication Skills

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Dexcom Medical Affairs is looking for 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, as well as design and management of compliant literature search strategies that support these deliverables and align with corporate objectives. Additionally, you will develop abstracts, posters, and manuscripts that communicate Dexcom evidence to external audiences – aligned with GPP/ICMJE guidance and internal publication processes. This is a great opportunity to help shape the function and work with some 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 management of vendor 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 (eg, 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 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 report Previous experience in diabetes preferred You bring In-depth knowledge of industry regulations and guidelines governing publications and medical communications You bring 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. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience. Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $95,900.00 - $159,900.00

Responsibilities

You will lead the authoring and updates of Clinical Evaluation Reports (CERs) and supporting documents, as well as manage literature search strategies for regulatory filings. Additionally, you will write high-quality scientific publications and ensure adherence to deadlines for deliverables.