Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Medical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Senior Representative, Medical Operations plays a key role in coordinating all administrative aspects of the proctor program, physician training, and digital excellence initiatives. This position is integrated into operations and is essential for accurate and timely expense reporting.
How you'll make an impact:
Conduct periodic audits of documentation and may participate in internal master file audits
Interact with clinical sites to resolve more complex device accountability issues
Provide training and technical support for internal and external users and set-up of new users in Wavemark
Review and ensure accuracy and completeness of clinical study files and/or device accountability logs, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
Provide coaching and training to lower-level employees
What you'll need (Required):
H.S. Diploma or equivalent 4 years’ related experience
What else we look for (Preferred):
Expense Reporting & Compliance: Lead monthly expense reporting and auditing for the U.S. Proctor Program and physician training initiatives, ensuring accuracy, timeliness, and adherence to compliance standards.
Physician Training Records & AI Integration: Manage end-to-end processing of physician training and proctor sign-off documentation in SharePoint. Organize and prepare files for AI-driven OCR workflows, ensuring seamless data capture and compliance. Conduct audits of historical records to maintain completeness and regulatory integrity.
Data Verification & Quality Assurance: Validate AI-extracted data, resolve discrepancies, and enforce quality control measures to safeguard data accuracy and reliability.
Onsite Physician Training Support – Irvine: Provide operational support for field-based physician training activities at Irvine, ensuring smooth execution of HCP education programs.
HCP Credentialing & BioCard Management: Support the HCP nominations process and maintain and update HCP BioCards and credentialing documentation, supporting accurate and current physician profiles.
Contribute to cross-functional projects, process improvements, and strategic initiatives that advance Medical Affairs operational excellence.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $60,000 to $84,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.