COMPLIANCE LEADER CONTROLLED SUBSTANCE MONITORING

JOB DESCRIPTION

Lead, develop and implement controlled substance compliance monitoring plans related to the distribution, handling and dispensing of controlled substances within the company to facilitate the timely identification of controlled substance compliance related risks, implementation of effective mitigation strategies and required compliance reporting. Collaborate with executive leadership and key stakeholders to maintain an effective Controlled Substance Compliance Program (CSCP). Serve as the subject matter expert (SME) for controlled substance compliance monitoring matters and is knowledgeable of applicable laws, regulations, and standards, including but not limited to the Controlled Substance Act, and the rules and regulations overseen by the Drug Enforcement Administration (DEA). Demonstrate the company's core values of respect, honesty, integrity, diversity, inclusion and safety.

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• Lead internal cross functional teams for advancing the CSCP strategy development and implementation of the company's controlled substance compliance monitoring plans
• Develop the strategy, implement, and direct monitoring activities related to controlled substances in company pharmacies and distribution suspicious order monitoring (SOM) requirements, aligning with regulatory requirements, other obligations and organizational goals
• Develop the strategy, implement, and direct monitoring activities related to controlled substance distribution suspicious order monitoring, aligning with regulatory requirements, other obligations and organizational goals
• Develop protocols to ensure up-to-date and organized compliance records are maintained; ensure timely preparation and submittal of required reports
• Ensure timely and accurate reporting to regulatory bodies, internal stakeholders and executive leadership, including preparation of compliance reports and audit documentation
• Collaborate with corporate affairs to comment and lobby on federal and state legislative matters; participate in industry forums related to their compliance area
• Serve as SME and remain current on evolving regulations, standards, directives, and industry guidance
• Educate internal team members and external parties on compliance regulations, processes, and procedures.
• Advise business unit leadership on best practices to ensure compliance with controlled substance regulations and other obligations
• Provide guidance to executives in executing risk assessments and implement and manage data-driven risk assessment tools and methodologies to proactively address and track compliance issues
• Review reports and conduct broad, in depth, analysis of various compliance metrics to identify trends and lead the resolution of potential vulnerabilities
• Identify key performance indicators and key risk indicators that measure and monitor potential risk areas.
• Collaborate with leadership to respond to inquiries from regulators
• Collaborate with internal and external partners and vendors that support the CSCP's monitoring program to enhance compliance efforts and integrate best practices
• Lead and oversee quality assurance protocols and internal audit activities of the CSCP's monitoring processes and lead remediation efforts of any resulting findings in a timely manner
• Drive continuous improvement initiatives to enhance data accuracy, efficiency, and overall effectiveness of the compliance program
• Lead projects at the direction of the Kroger Health Compliance Officer and Director of Controlled Substance Compliance
• Travel independently to various departments/division and industry meetings, including to oversee training and audits (approximately 10%)
• Supervise and coach direct reports in the performance of their duties; complete performance reviews and provide direct feedback to direct reports
• Must be able to perform the essential job functions of this position with or without reasonable accommodation

• Bachelor's degree in relevant field
• 8+ years of professional experience within their regulatory area
• 4+ years of diversified leadership, communication, organization, and people motivation skills or equivalent experience in the healthcare or pharmaceutical industry
• Strong leadership skills
• Strong analytical skills and ability to synthesize analysis into compelling oral and written communications and presentations
• Excellent planning, organizing and follow-up skills with attention to detail and thorough documentation practices
• Ability to organize and prioritize work based on changing and challenging deadlines
• Highly collaborative individual, who has proven ability to work cross functionally and build strategic and mutually beneficial relationships at all levels of the organization
• Ability to be self-directed and work independently

• Master's degree in relevant field
• Prior compliance management or consulting experience
• Current Certification in compliance area