Meet the team:Clinical Customer Advocacy is a team of health professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from Registered Nurses, Licensed Practical Nurses, Nurse Practitioners, and Pharmacists. The team is responsible for completing independent medical safety assessments for Dexcom products by proactively obtaining, reviewing, evaluating data and reports containing safety information, and post market surveillance activities. As a Sr Clinical Customer Advocate, the role will require collaboration with multiple internal Dexcom functions, Medical Affairs, Quality Assurance, Research & Development, Engineering, Regulatory Affairs, Clinical Affairs, Human Factors, Legal, and Technical Support in addition to external functions by providing support to Health Care Professionals and Dexcom customers. To succeed in this role, you must be systematic, highly organized, articulate, and able to work in a team environment that is fast paced with constantly shifting priorities.
Where you come in: - You will ensure medical validity and provide input into the activities of Customer Advocacy and Quality teams.
- You will follow documented procedures, produce and document medically accurate assessments to include elements such as coding, causality, seriousness, and case narratives.
- You will assess and appropriately escalate product issues that require elevated review and safety signals.
- You will provide input on responses to adverse events, review internal and customer safety materials, input into design and interpretation of global post-market safety studies, and evaluate the medical impact of manufacturing issues.
- You will execute post market surveillance activities in compliance with applicable global regulations, such activities include post market plans, PSUR, CER, literature reviews, design control, and risk management.
- You will review and provide input to complaints regarding serious adverse events. Contact medical professionals for additional information as required.
- You will execute medical triage for appropriate causality on investigational assessment documents supporting regulatory reporting and post market surveillance activities.
- You will assist in providing safety trend analyses and related periodic review meetings.
- You will perform other duties related to the position as necessary as defined in company's SOPs or requested by his/her supervisor.
What makes you successful: - You'll need a minimum of 4-12 years of related experience with a bachelor's degree, Registered Nurse preferred.
- Your certification as a Certified Diabetes Care and Education Specialist (CDCES) is highly desirable.
- Your knowledge of and clinical experience in field of diabetes and CGM technology are highly desirable.
- Your experience in Post Market Surveillance, such Post Market Plans, PSUR, CER, and literature review is preferred.
- Your experience in Safety Vigilance monitoring and Adverse Event case processing/reporting or Risk Management are desirable.
- Ability to interpret company policies and procedures to complete a variety of tasks.
- Must be self-motivated, self-confident, and be able to work independently or equally well as a team member. Demonstrated ability for teamwork and collaborative problem-solving.
- Other important qualities include excellent written and verbal communications skills, attention to detail, consensus building and teamwork, planning and implementation 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: Education Requirements: - Typically requires a Bachelor's degree and 5-8 years previous experience.
Preferred Qualifications - 4+ years of clinical experience.
- 2+ years of experience supporting Post Market Surveillance, Medical Device Reporting (MDR), and Product Vigilance activities.
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.
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.
Salary:
$95,900.00 - $159,900.00
#DexcomUS
