Specialist, Training and Documentation THV

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 Clinical 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 under-treated. 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.

You will make an impact by:

• Conduct regular assessments to verify individual training activities and training curriculum for each role in the global THV Clinical Affairs function. Analyze training data, evaluate compliance reports and complete customized reporting dashboards to ensure company metrics are achieved
• Assess current and new processes, implementing solutions to improve process efficiency within and across related functional areas
• Identify technical and/or process issues to determine root cause, propose recommendations
• Function as an LMS Super-User for first-line support to the global THV CA staff. Provide cross-functional user guidance to facilitate the performance of their required training. Act as a liaison between the corporate LMS team and individuals for unresolved issues. Communicate with the LMS team and escalates as necessary for unresolved issues
• Collaborate with managers to develop training requirements for individuals and to regularly review/revise training course curriculum for accuracy and relevance. Maintain a solid grasp of training content to cross-reference documentation and identify where change in one document/plan may lead to a change in another document/plan. Enter Training Plans for new individuals or individuals with role changes
• Function as an Ignite Super-User to the global THV CA staff. Initiate, launch workflows, and follow-up on Engineering Change Requests (ECRs) Format and revise documents for upload into Ignite or other document repository. Communicate new and revised document releases to appropriate THV Clinical Affairs functions
• Provide monthly and ad-hoc training reminders to individuals with respect to new courses content and overdue courses to ensure all assignments are compliant with department and company goals
• Compile corporate training records and document requests for compliance assessments/audits
  

What you will need (Required):

• Bachelor's Degree
• A minimum of 3 years related experience
• Experience managing an electronic training/tracking learning management system
• Experience utilizing a document product lifecycle management system, preferably Ignite or Teamcenter

What else we look for (Preferred):

• Experience in clinical trials or regulatory compliance
• Good understanding of global medical device regulations, including FDA, ICH, GCP, and ISO regulations and quality management systems

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 $66,000 to $94,000 (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.