The Sr. Manager, Global Ethics & Compliance will provide leadership and direction on the company's ethics and compliance program, including its global business practice standards and all interactions with health care providers.
Serve as an advisor on complex ethics and/or HCP interactions and provide guidance to the business. Manage approval structure for HCP contracts and review non-standard agreements.
Provide direction and guidance to project teams to execute larger ethics and/or HCP projects, initiatives and/or programs including provide coaching and knowledge transfers.
Develop training and conduct instructor led training.
Identify and evaluate more complex process improvements and/or course correction/alignment opportunities including the monitoring of ethics and HCP policies and procedures.
Conduct third party due diligence. Lead or participate as member of third party management committee.
Assist in conducting investigations where decisions have an extended impact on work processes and outcomes.
Conduct policy and procedure reviews and update ensuring clarity and adoption of best practices
Track progress of all violations of policies, ensuring consistent processing, treatment and disposition.
Lead regional compliance committee; Participate in regional industry association meetings.
Conduct regional risk assessments.
Analyze and track key metrics for senior leadership.
Bachelor's Degree in related field with 12 years in legal, internal audit, finance, and/or health care compliance is required; OR Master's Degree or equivalent in related field with 10 years in legal, internal audit, finance, and/or health care compliance is preferred.
Experience in pharma and/or medical device is required.
Experience working in a large manufacturing company is a plus.
Proven successful project management skills.
Proficient in Microsoft Office Suite and related tools and systems.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Recognized as an expert in own sub-function(s) and/or area(s) within the organization with broad-based advanced knowledge within the organization.
Expert knowledge and understanding of Edwards’ policies, procedures, and guidelines relevant to compliance.
Expert knowledge of Industry Code requirements.
Expert understanding of related aspects of healthcare regulations (e.g., U.S. federal anti-kickback law, OIG Guidelines for Pharmaceutical Manufacturers, U.S Sentencing Guidelines, AdvaMed Code of Ethics and related regional codes of conduct on interactions with health care professionals, Foreign Corrupt Practices Act, UK Anti-Bribery Act and other related laws, rules, and regulations).
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast paced environment.
Ability to participate and present at meetings with internal and external representatives.
Ability to resolve operational and scheduling issues.
Ability to dedicate to quality client service and pro-active and responsive to client needs.
Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Ability to develop relationships and leverage them to influence change.
Ability to support and solicit input from team members at all levels within the organization.
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.
Internal Number: 020916
About Edwards Lifesciences
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 13,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.