Edwards Lifesciences Associate Manager, Physician Training – Clinical Education and Training - TMTT in Irvine, California
Associate Manager, Physician Training – Clinical Education and Training (Irvine, CA) TMTT
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. Join a fast-paced, dynamic team and play a pivotal role in the development of new therapies and devices, from concept through launch and commercialization of groundbreaking technology.
The Associate Manager, Physician Training will play a critical role in Transcatheter Mitral & Tricuspid Therapies (TMTT) clinical study execution including leading the internal specialist training program and maintain an audit ready environment by ensuring compliance with all physician and training procedures, maintain drive high levels of accuracy and compliance.
This position is Irvine based, but will consider remote for candidates with exceptional experience.
Lead and drive the TMTT training program through curriculum execution, standardization, content development, SME resource management, and documentation to ensure study compliance, as it relates to physician and clinical specialist training, in accordance with regulations and corporate processes. Maintain regular contact and collaborate with partner TMTT clinical teams, cross BU partners, consultants, customers and network appropriately with relevant stakeholders.
Develop content as it relates to specialist training topics for best in class practices as they relate to required non-procedural knowledge.
Train and evaluate the quality of team members execution of specialist and physician training processes and documentation as it relates to physician and clinical specialist training.
Responsible for maintaining an audit ready environment for all aspects of regulatory and non-regulatory audits as it relates to training (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.) Lead assessment of teams’ compliance to GSOPs, work instructions, protocols, LMS and regulatory requirements. Lead audit preparation efforts for TMTT including team education, process development, timeline management, communication and implementation.
Identify, acquire, develop and maintain programs used for electronic documentation records and processes (e.g., Trifecta, Veeva Vault, Litmos) for both internal and external training.
Strategically develop and lead the delivery of training programs for TMTT training on best practices, trends, regulatory requirements and published guidance, policy and procedure updates, etc.
Review and contribute to the development of policies, physician training documentation, clinical specialist training, and other documents to be audit ready.
Manage, leverage and communicate detailed metrics reporting including training compliance and employee training dashboards to drive compliance.
Assess, manage and ensure the resolution of audit findings and protocol deviations while developing priorities and strategies to drive compliance.
Lead the development, continuous improvement and streamlining of processes and procedures to ensure efficiency and accuracy in accordance with regulatory and company requirements.
Other incidental duties: Lead resources tasked with training logistics
Bachelor’s or equivalent 4-year degree in Life Sciences
Will also consider Associate’s degree in clinical (ie: RN, RDMS, CVT) plus 2 additional years above minimum required experience.
Minimum of 8 years of experience with physician education and training obtained from medical device industry or combination of medical device and healthcare industries
Direct clinical experience may substitute for some industry experience.
Must have medical device industry experience.
Ability to travel up to 50%
Strong structural heart or cardiovascular knowledge.
RN, Cath Lab Tech, Echo Imaging backgrounds preferred.
Additional Talents and General Expectations:
Proven successful organizational and project management skills
Proven expertise in Microsoft Office Suite
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Extensive understanding of related aspects of clinical therapeutic areas
Extensive knowledge of regulatory, compliance, and AdvaMed requirements
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
Maintain a strong relationship with the regional sales team, clinical specialists, and training to ensure effective and optimal integration of efforts.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.