Manager, Physician Training

Edwards Lifesciences

18d • $136,000 - $193,000

About The Position

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. How you will make an impact: The Manager Physician Training THV will play a critical role in assigned Business Unit 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 Lead and drive the Business Unit 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 BU 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 BU 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 BU 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.

Requirements

• Bachelor's Degree or Equivalent
• 8 years experience of work experience with strong clinical background or equivalent work experience based on Edwards criteria
• 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
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

Nice To Haves

• Education completed with a certificate of Registered Nursing, RTExperience working in healthcare industry or equivalent work experience based on Edwards criteria

Responsibilities

• Lead the internal specialist training program and maintain an audit ready environment by ensuring compliance with all physician and training procedures
• Lead and drive the Business Unit 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 BU 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 BU 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 BU 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.
• Lead resources tasked with training logistics.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees