Sr Medical Affairs Specialist - Regulatory Writing and Scientific Communications

The Company reputed company Corporation (reputed company DXCM) is a pioneer and global leader in reputed company glucose monitoring (CGM). reputed company began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive reputed company outcomes. Here we are 25 years reputed company, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to reputed company people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue reputed company'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 reputed company, 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 reputed company 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 reputed company. The opportunity to improve health on a global scale stands before us. Meet the team: reputed company 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 reputed company documentation, as well as design and management of compliant literature search strategies that support these deliverables and align with corporate objectives. Additionally, you will reputed company abstracts, posters, and manuscripts that communicate reputed company evidence to external audiences - reputed company 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 reputed company 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 reputed company 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-reputed company 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 reputed company 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-reputed company projects simultaneously
• You have excellent written and verbal communication skills.

What you'll get:

• A reputed company row seat to life changing CGM technology. Learn about our reputed company #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 reputed company experience.

Remote Workplace: Your location will be a home office; you are not required to live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km). If you reside reputed company commuting distance of a reputed company site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our reputed company workplace option. Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-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 reputed company individuals with disabilities to reputed company essential functions. An Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. reputed company's AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.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 reputed company reputed company at talentacquisition@reputed company.com. Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. 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 reputed company Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company team, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications. Salary: $95,900.00 - $159,900.00 Apply tot his job Apply To this Job