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Director, US Healthcare Compliance Business Advisor

Edwards Lifesciences

Irvine, CA

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JOB DETAILS
SALARY
$145,000–$205,000 Per Year
SKILLS
Analysis Skills, Best Practices, Biotech and Pharmaceutical, Business Activity Monitoring (BAM), Business Operations, Business Practices, Business Strategy, Career Counseling, Coaching, Communication Skills, Consulting, Corrective Action, Cross-Functional, Customer Support/Service, Detail Oriented, Documentation, Drug Manufacturing, Environmental Health, Financial Audit, Funding, Government, Healthcare, Healthcare Providers, Internal Audit, Interpersonal Skills, Leadership, Legal, Maintain Compliance, Medical Equipment, Metrics, Microsoft Office, Patient Care, Pollution Prevention, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Project Tracking, Project/Program Management, Regulations, Resolve Customer Issues, Risk Analysis, Risk Management, Safety/Work Safety, Strategic Planning, Team Player, Time Management, Training/Teaching, Trend Analysis, Vaccination
LOCATION
Irvine, CA
POSTED
30+ days ago
At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.


Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Director, US Healthcare Compliance Business Advisor position is a unique career opportunity that could be your next step towards an exciting future.


This role can be a fully onsite or hybrid role based at our Irvine headquarters.


How you’ll make an impact:


The Director, US Healthcare Compliance Business Advisor provides strategic Compliance expertise, leadership, and trusted business partnership across Edwards’ Ethics and Compliance program, with a focus on U.S. business practices involving interactions with health care professionals and health care organizations.


This partnership-minded Compliance leader will have the opportunity to help guide the US Business organization across several pillars of Edwards’ Compliance program – governance, policies, trainings, communications, and monitoring. The Director will deliver proactive, solutions-oriented Compliance guidance and collaborate closely with business partners to design and implement robust controls, policies, trainings and communications.


+ Serve as a strategic compliance leader, business partner and advisor on standard and complex ethics and compliance business operations and initiatives (e.g., Healthcare Organizations/ Healthcare Professionals interactions); provide directions and guidance to project teams to execute larger ethics and/ or Healthcare professional/ healthcare organization projects, and/ or programs including coaching and knowledge sharing.


+ Manage, review, and approve business transactions with healthcare professionals and healthcare organizations, including providing consultative advice; identify, evaluate, and implement refined compliance process improvements and/ or course corrections/ alignment opportunities as deemed necessary.

+ Develop and update US compliance policies, guidance, job aids, and other resources for internal stakeholders and update such resource as necessary

+ Develop and update US Compliance training plans including the creation of compliance training materials and delivery of instructor-led training

+ Assist in US risk assessments, investigations, and monitoring of business activity and track progress to completion of corrective action plans, as needed.

+ Lead regional compliance committees; participate in regional industry association meetings; participate in Business committees (Grant Review Committee, Business Unit Leadership Committees, etc.) as deemed necessary; analyze, track, and report key metrics for senior leadership.

+ Incidental activities as needed


What you’ll need (Required):


+ Bachelor's Degree in related field and 12 years experience in legal, internal audit, finance, and/or health care compliance or equivalent work experience based on Edwards criteria, OR

+ Master's Degree or equivalent in related field and 10 years experience in legal, internal audit, finance, and/or health care compliance or equivalent work experience based on Edwards criteria


What else we look for (Preferred):


+ Experience working in US Healthcare Compliance in a large Medical Device, Pharmaceutical, and/or Biotech company.

+ Knowledge of Compliance-related government enforcement trends.

+ Expert knowledge and understanding of US Healthcare Compliance policies, procedures, and guidelines.

+ Expert understanding of related aspects of healthcare regulations (e.g., U.S. federal anti-kickback law, False Claims Act, Sunshine Reporting Requirements, 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).

+ Technical expertise across all pillars of an effective Compliance program – policies, training, communications, and monitoring

+ Strong capabilities in risk management and monitoring that help drive informed decision-making and enable the business to operate with integrity, accountability, and sustainable access

+ Ability to participate and present at meetings with internal and external representatives at all levels of the organization (i.e., analyst to SVP/EVP level).

+ Ability to effectively present live Compliance training to small and large audiences and ability to answer Compliance questions during those trainings.

+ Ability to conduct Compliance monitoring on the transactional and aggregate level on HCP/HCO activities (HCP Consulting Arrangements, Speaker Programs, External Funding activities, HCP meals and T&E, etc.).

+ Enterprise-wide level thinker and ability to strategize and plan for identified Compliance risks

+ 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 partnership and collaboration 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

+ Ability to interact professionally with all organizational levels.

+ Ability to manage competing priorities and act timely in a fast-paced environment.

+ 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 support and solicit input from team members at all levels within the organization.

+ Strict attention to detail.

+ 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


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.


For California, the base pay range for this position is $145,000 to $205,000 (highly experienced).


The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.


#LI-Hybrid


Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.


COVID Vaccination Requirement


Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

About the Company

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Edwards Lifesciences