Edwards Lifesciences Associate Manager, Physician Training - TMTT in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding opportunity for you to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up!
The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization. We are open to considering candidates who live outside the Southern California area, open to up to 50% travel and willing to work PST hours.
Lead and drive TMTT (Transcatheter Mitral and Tricuspid Therapies) training programs 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 TMTT clinical teams, cross BU partners, consultants, vendors, physicians, and clinical research staff while networking appropriately with relevant stakeholders
Collaborate with physicians and SMEs to develop educational content as it relates to clinical specialist and/or physician training topics for best in class practices
Train and evaluate the quality of team members execution of 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
Strategically develop and lead the delivery of training programs for TMTT 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
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
Manage project status and appropriate communication both internally and externally
Lead resources tasked with training logistics for both internal and external training events in collaboration with cross functional team members
Manage and assist with internal and physician training events working with lab facilities within Edwards and contracted vendor sites
As directed by the Physician Training Manager, assumes the leadership role in departmental meetings, project management tasks, cross functional collaboration and other duties as assigned
Minimum 8 years of experience
Experience working in healthcare industry with clinical background (marketing, sales training, clinical/imaging) strongly preferred
Proven successful organizational and project management skills
Excellent problem-solving, analytical, and critical thinking skills
Proven expertise in Microsoft Office Suite with high attention to detail and output
Ability to manage competing priorities in a fast-paced environment
Work is performed independently on complex projects and or lines of work and reviewed for accuracy and soundness
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Excellent documentation, communication, 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
Maintain a strong relationship with Case Support and Training team 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.