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

How you will make an impact:

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.

What you will need (Required):
Bachelor's Degree or Equivalent 8 years experience of work experience with strong clinical background Required
Experience working in healthcare industry Preferred

What else we look for (Preferred):
• 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 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

What is it like to work at Edwards Lifesciences in Germany?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in Germany also offers the following benefits:

Competitive compensation and benefits package
Flexible working hours, remote working
Pension plan
Risk insurance
Service awards
Enhanced leave benefits
Employee stock purchase program
Employee assistance program
Comprehensive wellness program including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefit policy and components may vary by location

Edwards Lifesciences

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