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Job Summary

JOB DESCRIPTION

The Sr. Director, Compliance will help oversee the global compliance program and provide a broad range of compliance support throughout the Company; partnering with the business to sustain the Company’s ethical and compliant culture. This position reports to the EVP, General Counsel and Chief Compliance Officer.

The successful candidate will have previous industry experience and be familiar with applicable U.S. and international laws, regulations, and industry standards pertaining to the medical device or pharmaceutical industry (Anti-kickback Statute, False Claims Act, Physician Payments Sunshine Act, and Foreign Corrupt Practices Act, AdvaMed, MDMA).

Duties & Responsibilities

• Oversee the global compliance program and take a leadership role in promoting ethical behavior and compliance with applicable federal, state, and global anti-kickback laws and regulations.
• Actively engage with business partners to understand and provide proactive compliance guidance on the development and execution of proposed strategic and tactical initiatives.
• Advise business units on developments and matters related to the compliance program as well as relevant healthcare industry legal and compliance developments.
• Conduct reviews of global business activities to ensure compliance with AKS, FCA, FCPA, and international anti-corruption laws and regulations.
• Maintain strong understanding of and work to implement U.S. and international industry codes of ethics on interactions with healthcare providers.
• Work collaboratively across the business to develop, update, and implement compliance policies and procedures that are right-sized for the Company and reflective of applicable laws, regulations, guidance, and industry codes of ethics.
• Provide compliance oversight and participate, as required, in review and approval processes for grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare providers and healthcare organizations
• Oversee the global HCP transparency reporting for U.S. “Sunshine Act” and applicable international disclosure regulations.
• Develop and execute a comprehensive compliance training program to help employees and designated third parties understand and be accountable for applicable compliance policies, laws and regulations.
• Oversee risk-based compliance audit and monitoring activities and other oversight programs for key areas of risk and remediate where necessary.
• Oversee investigations into allegations of violations of applicable laws, regulations, or policies and recommend corrective action where appropriate
• Maintain effective compliance communication channels for the Company by promoting awareness of the Code of Business Conduct and Ethics, the use of the Compliance Hotline, as well other means for employees to report compliance-related concerns or engage with senior leadership
• Ensure compliance with corporate disclosure requirements such as California Transparency in Supply Chains Act, UK Modern Slavery Act, AU Modern Slavery Act, etc.
• Foster strong internal compliance, ethics, and speak-up culture

Minimum Qualifications

Minimum & Preferred Qualifications and Experience:

• A minimum of 8 years’ of direct experience in a Compliance department of a healthcare company (medical device, pharma/biotech)
• At least 5 years’ experience leading a compliance team and successfully managing people
• Knowledge of federal, state, and international laws and industry requirements affecting the medical device/pharma/biotech industries
• Excellent interpersonal, communication and written skills, proven ability to work independently with a wide range of stakeholders

Preferred Qualifications

• Ability to apply a risk-based analysis to compliance issues and demonstrate creativity in developing solutions that satisfy legal and ethical obligations
• Strong analytical and communication skills, attention to detail, and pragmatic and practical approach
• Ability to work efficiently and independently, prioritize workflow, meet deadlines, and manage multi-faceted projects in a fast-moving environment
• Ability to interact positively and provide guidance within all levels of management and staff
• Ability to travel up to 15% may be required

Education

• Bachelor's Degree (public policy, business, finance/accounting or related discipline preferred)
• Graduate-level degree preferred (JD, MBA, or related discipline)
• Certification in Healthcare Compliance (CHC) preferred

Compensation : The anticipated range for this position is $225,000 - $275,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.