Manager, Global Ethics & Compliance

POSTED ON 5/2/2022 CLOSED ON 10/28/2022
Edwards Lifesciences LLC Hired Organization Address Redhill/MLE, PA Full Time

Job Posting for Manager, Global Ethics & Compliance at Edwards Lifesciences LLC

We’re looking for compliance professionals with HEART. Edwards Lifesciences has an opening for a key leader to advance our ethics and compliance program in the U.S., including global business practice standards and all interactions with health care providers. A Day in the Life: • Manage, review and approve health care provider service agreements, clinical study agreements, requests for grants and sponsorships, and company-hosted events for health care providers • Advise business partners on complex transactions and interactions with health care professionals • Serve on grant review committees and provide subject matter expertise • Develop and update global monitoring plan to ensure compliance and mitigate risks; manage U.S. compliance monitoring to test compliance with healthcare policies and procedures, including development of templates and metrics for tracking and trending, and providing appropriate guidance to internal stakeholders • Develop and update global training plan; develop training materials and deliver instructor led training. Develop job aids and other resources for internal stakeholders and update such resources on the intranet. May author compliance bulletins and distribute where appropriate • Conduct third party due diligence. Participate in third party management committee • Assist in conducting routine investigations • Assist in and track progress of potential violations of policies in central case management system, ensuring consistent processing, treatment and disposition • Compile, analyze, and track key metrics for senior leadership • May participate in local medical device trade association meetings • May present topics (e.g., industry trade association news, compliance policy revisions, status updates on investigations, compliance metrics data, and other disciplinary matters etc) during Regional Compliance Committee meetings • Other incidental duties *This role is hybrid. Opportunity to work remote with the expectation to be onsite a few days of the week. Required Education and Experience: • Bachelor's Degree a minimum of 8 years of work experience • Experience must be in legal, internal audit, finance, and/or health care compliance • Pharma, Biotech or Medical Device industry required • Experience applying knowledge of healthcare regulations (e.g., U.S. federal anti-kickback law, OIG Guidelines for Pharmaceutical Manufacturers, U.S Sentencing Guidelines, AdvaMed Code of Ethics on Interactions with Health Care Professionals, Foreign Corrupt Practices Act, UK Anti-Bribery Act and other related laws, rules, and regulations) Preferred Education & Experience: JD or Law Degree highly preferred Additional Required Skills: • Extensive knowledge of Industry Code requirements • Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) required; Experience in JDE or SharePoint preferred • Proven successful project management skills • Excellent facilitation and presentation skills • Excellent creative problem analysis and resolution skills • Excellent written and verbal 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 knowledge and understanding of Edwards policies, procedures, and guidelines relevant to compliance • 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 • Represent leadership on projects within a specific area interfacing with project managers and cross-functional teams • • Ability to apply business acumen in advising business partners on complex challenges • Ability to develop and maintain strategic partnerships • 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 Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

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