COMPLIANCE MANAGER, CONTROLLED SUBSTANCE COMPLIANCE MONITORING

Job Description

Responsible for the company's compliance with the Controlled Substance Compliance Program's (CSCP) monitoring plans related to the handling and dispensing of controlled substances in company pharmacies. Lead, implement and oversee the CSCP's monitoring and reporting procedures, quality of monitoring activities, and enhancement activities to facilitate timely identification of controlled substance compliance related risks, implementation of effective mitigation strategies and required compliance reporting. Collaborate with the Controlled Substance Compliance Monitoring Leader to identify short- and long-term initiatives, and plan for ongoing enhancement and evolution of the program over time. Demonstrate the company's core values of respect, honesty, integrity, diversity, inclusion, and safety.

Responsibilities

• Lead, develop, implement, and monitor the CSCP's policies and procedures and assure company endorsement of these programs and compliance with all applicable federal and state laws, regulations and guidance relating to compliance with controlled substance regulations and other obligations
• Maintain a working knowledge of all federal, state, and local regulations as well as industry standards and guidance as it relates to the CSCP; build a positive working relationship with regulatory agencies
• Maintain up-to-date and organized compliance records and ensure timely preparation and submittal of required reports
• Manage all aspects of the CSCP monitoring program, including providing training on all relevant topics; review audits and risk assessments to determine compliance status
• Review key performance indicators and key risk indicators to measure and monitor potential risk areas; report high risk activity in a timely manner to appropriate stakeholders
• Ensure maintenance of required management information systems
• Ensure audits of compliance programs are conducted and provide regular periodic reporting on compliance efforts to inform compliance and division leadership
• Complete and submit correspondence and compliance reports for their programs; distribute information to associates and agencies; ensure a system to accurately file reports is in place to meet compliance requirements
• Represent and assist with responses to agency inspections and alleged compliance violations and assist with investigations and remediation
• Lead and manage a team of analysts, providing guidance, support and professional development
• Supervise and coach direct reports in the performance of their duties; complete performance reviews and provide feedback to direct reports
• Partner with all internal departments to evaluate new processes, procedures and materials to determine impact
• Keep abreast of new industry technologies
• Identify opportunities for continuous improvement
• Travel up to 25%
• Must be able to perform the essential job functions of this position with or without reasonable accommodation

Qualifications

MINIMUM

• Bachelor's Degree in relevant field or 8+ years of relevant experience
• 5+ years of compliance experience, with preferred experience in the healthcare or pharmaceutical industry
• Self-directed, ability to execute projects with minimal supervision
• Ability to comprehend complex regulations, interpret requirements, and translate into operations
• Demonstrated success with implementation of regulatory requirements
• Good administration and management skills. Good writing and communication skills
• Ability to direct peers, supervisors, and hourly personnel in projects to obtain and maintain compliance; ability to relate well with others and inspire good job performance
• Ability to work cooperatively in high paced and sometimes stressful environment
• Ability to manage conflict in a reasonable, nonconfrontational and cooperative manner
• Ability to act with honesty and integrity regarding customer and business information
• Ability to follow directions and seek assistance when necessary to resolve customer and business issues
• Provide support and assistance through direct interaction with minors, individuals with special needs, and/or older adults
• Demonstration of project management skills, including budgeting and scheduling

DESIRED

• Experience in the pharmaceutical or healthcare industry
• Prior compliance management or consulting experience
• Recognized certification in compliance area