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Staff Regulatory Affairs Specialist- Ad Promo

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Salary: 
111 - 185K yearly
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor's degree needed; 8-12 years' experience., 5+ years in reviewing advertising materials for medical devices., Experience using Veeva PromoMats is required., 10+ years in medical device or biopharmaceutical industry desired., Global regulatory experience is highly preferred..

Key responsabilities:

  • Support the regulatory affairs team reviewing marketing claims.
  • Collaborate with marketing and clinical teams on promotional materials.
  • Enhance processes for managing advertising and promotional content.
  • Train global cross-functional teams to ensure compliance best practices.
  • Act as a subject matter expert in regulatory strategies.
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Dexcom XLarge https://careers.dexcom.com/
10001 Employees
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Job 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:

Join our world-class regulatory team! Be an important contributor in our team as we bring Dexcom’s innovative new products to market across the world. Use and develop cutting-edge regulatory competencies in this fast-paced global-scope team with an outstanding track record of successes. Be a part of the team that enables more and more people around the world to improve their health as they use our Dexcom Continuous Glucose Monitoring (CGM) products! Interact across this dynamic organization as you lead activities of regulatory and train cross-functional professionals to develop world-class compliant Advertising and Promotional materials to promote our world-class Dexcom products.

Where you come in:

  • You will provide direct support to regulatory affairs team members reviewing and approving marketing claims, labeling, and advertising and promotional materials for life altering Dexcom products.
  • You will closely partner with marketing, clinical, medical affairs, and other functions as you develop and approve impactful compliant advertising and promotional materials.
  • You will work to continuously improve the process of creating, approving, and managing advertising and promotional materials within Dexcom, including training our global Regulatory and cross-functional teams to Advertising and Promotional best practices.
  • You will partner within the broader regulatory affairs team performing as a subject matter arbitrator as we implement critical regulatory functional strategies, align on common standards and successfully complete regulatory and business goals.

What makes you successful:

  • You have strong written and verbal communication skills. You communicate and collaborate effectively with cross-functional advertising and promotional partners to ensure alignment, and timely review of compliant work materials.
  • You are passionate about continuous improvement and adapting to change to ensure compliance and efficient work.
  • You have current knowledge and 5 or more years of experience in the review of Advertising and Promotional materials for medical devices.  Experience using Veeva PromoMats is required.
  • You can find and implement solutions to sometimes complex challenges.
  • You are motivated by working at a fast pace.
  • 10 or more years of experience with the medical device or biopharmaceutical industry is required. Global Regulatory experience is highly desired.
  • You have a demonstrated interest in diabetes and health technology (a huge plus!).
  • You are highly flexible and able to shift priorities as needed.
  • Ability to communicate in language(s) other than English is desired.

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 8-12 years of related experience.
  • • At this level a graduate degree may be desirable with 4 years of related experience

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. 

View the OFCCP's Pay Transparency Non Discrimination Provision at this link

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:

$111,100.00 - $185,100.00

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Problem Solving
  • Verbal Communication Skills
  • Adaptability
  • Intercultural Communication
  • Collaboration

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