Edwards Lifesciences Associate Manager, Medical Affairs (Remote US) THV in San Diego, California
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
The THV Medical Affairs department is a multi-functional team supporting FDA approved products and indications by fostering internal and external collaborations to generate and disseminate evidence-based best clinical practices to help save patients’ lives and advance quality of care. This role is with the Medical Affairs Physician Training team and will be integral to evolving and elevating current processes related to clinical case review and simulation strategy.
This role is responsible for the evolution of physician case review process, working closely with both internal and external physician advisors/proctors to improve and elevate resource. Key focus areas include project digitization on SalesForce.com (SFDC), identifying sales team knowledge gaps requiring remediation, and utilizing metrics to ensure appropriate utilization of resource.
Develop, execute, and oversee a best-in-class simulation program to support HCP training and education on safe and effective use of Edwards Lifesciences THV products in various approaches and techniques.
Key Responsibilities including but not limited to :
Lead the analysis of 3Mensio reports and provide guidance to the commercial team on clinical case review to determine suitability for SAPIEN implantation
Communicate directly with sales team requestor to clarify clinical case review requests to ensure physician reviewer has complete information for quality analysis Develop written work instructions, audit process and metrics to measure effectiveness of case review resource
Identify knowledge gaps for sales team related to case review and work with sales training on addressing deficits
Provide education and training to physician reviewers on both process and policy related to case reviews
Integrate simulation into all THV physician training courses/programs, enthusiastically promoting simulation as key to successful case outcomes
Act as a primary contact and SME for external simulation partners, keeping up to date on evolution of technology and identifying new features and opportunities to advance simulation program
Manage new project SOWs, monitor spend, and provide utilization metrics
Integrate Proficiency Based Progression (PBP) Training for Novice TAVR Operators
Lead the cross-functional simulation council to identify and understand various needs and opportunities to integrate simulation learning for HCPs treating patients with structural heart disease
Incorporate process improvement that drives program effectiveness, ensuring overall stakeholder satisfaction
Manage compliant engagement of HCP consultants, honorarium payment consistent with established consulting agreements and EW policy of HCP engagement
A minimum of 8 years of THV/TAVR experience including within healthcare industry
Formal education and clinical experience in one or more the following specialties/areas:
Interventional Cardiology/Cardiac Cath Lab, CT Surgery, Structural Heart Nursing (RN/BSN/MSN), Physician Assistant (PA-C), RCIS/CVT/RTR
Experience utilizing image viewing and processing software (e.g., 3Mensio, OsiriX, Vitrea, Circle, etc.) for CT and/or Echo Analysis
Experience providing simulation support for industry training
Ability to travel up to 50%
Extensive knowledge and understanding of policies, procedures, and guidelines relevant to interacting with HCPs
Extensive knowledge of regulatory, AdvaMed, Legal, Compliance requirements within MedTech industry
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Maintain a strong relationship with the regional sales team, clinical specialists, and training to ensure effective and optimal integration of efforts
Must excel at interacting and collaborating with sales colleagues and physicians
Proven successful organizational and project management skills
Proven expertise in Microsoft Office Suite
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast-paced environment
Must be able to work effectively within a specific area with cross-functional team, marketing peers and leaders and managing needs and messaging to upper management
For Colorado Residents Only:
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.
The base pay range for this position is $129,000 to $151,000.
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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