Senior Manager, Compliance

Position Summary

The Senior Manager, Compliance is responsible for the management of Corporate Compliance activities for all FFF Enterprises, Inc. business units, including Drug Wholesale Distribution and Specialty Pharmacy, and Inventory Management Solutions, with a dedicated focus on DEA compliance and other Corporate Compliance initiatives, training, investigation, auditing, monitoring, reporting and continuous improvement.

Essential Functions and Duties

• Assume responsibility in the management, development, and implementation of policies and procedures which minimize the exposure to the adverse effects of pharmaceutical diversion.
• Effectively manage and ensure appropriate DEA and applicable state-controlled substance agencies records and reports are accurately completed and filed in accordance with Federal and State regulations.
• Ensure all reporting is complete and comprehensive including but not limited to ARCOS, loss & theft, state requirements, and inventory reports.
• Carefully coordinate with regulatory affairs to ensure timely identification and implementation of new and amended laws, regulations and/or guidance.
• Support the Chief Compliance Officer and other members of the Compliance team in the implementation and management of enterprise wide corporate compliance program activities.
• Responsible for the development and implementation of internal compliance metrics, audits and reports, including reporting to the Corporate Compliance Committee.
• Implement and manage DEA and other compliance training programs for other departments working with controlled substances as necessary.
• Handle Drug Enforcement Administration Field Office interactions for all DEA related issues at designated sites and Boards of Pharmacy.
• Carefully coordinate and reconcile inventories at all applicable sites.
• Conduct investigations for the loss or theft of controlled substances in a timely manner.
• Support inspections and investigations.
• Other DEA and non-DEA specific compliance related responsibilities as necessary.

General Responsibilities

• Adhere specifically to all company policies and procedures, Federal and State regulations and laws.
• Display dedication to position responsibilities and achieve assigned goals and objectives.
• Represent the Company in a professional manner and appearance at all times.
• Understand and internalize the Company’s purpose, display loyalty to the Company and its organizational values.
• Display enthusiasm and dedication to learning how to be more effective on the job and share knowledge with others.
• Work effectively with co-workers, internal and external customers and others by sharing ideas in a constructive and positive manner; listen to and objectively consider ideas and suggestions from others; keep commitments; keep others informed of work progress, timetables, and issues; address problems and issues constructively to find mutually acceptable and practical business solutions; address others by name, title, or other respectful identifier, and; respect the diversity of our work force in actions, words, and deeds.
• Comply with the policies and procedures stated in the Injury and Illness Prevention Program by always working in a safe manner and immediately reporting any injury, safety hazard, or program violation.
• Ensure conduct is consistent with all Compliance Program Policies and procedures when engaging in any activity on behalf of the company. Immediately report any concerns or violations.

Education, Knowledge, Skills, and Experience Required

• Education: Bachelor’s Degree or four (4) years related experience in lieu of degree.
• Required Knowledge: Requires broad knowledge of DEA laws and regulations, applicable federal, state, and local laws, business administration, accountancy, sales, marketing, human relations, computer sciences, distribution, pharmaceutical manufacturing, pharmacy, distribution practices and systems, supplier management and procurement.
• Preferred Knowledge: Knowledge of and experience with Drug Distribution and/or Pharmacy laws and regulations helpful.
• Required Experience: Minimum of five (5) years [nine (9) for non-degreed candidates] of experience in pharmaceutical or healthcare compliance. Five (5) or more years in a manager position. Must have prior experience supporting or performing program management for large to mid-size corporation with projects that span considerations across people, processes, technology and external stakeholders. Requires broad training in fields such as compliance, business administration, federal and state healthcare regulatory requirements or similar. Previous experience managing and / or providing regulatory oversight. Demonstrated experience supporting DEA compliance and / or regulatory compliance function. Previous experience interacting with external regulatory agencies including DEA office(s) and Investigators. Experience with CSOS, SOM, and ARCOS systems.
• Preferred Experience: Investigative and diversion control background preferred.
• Required Skills: Exceptional regulatory acumen, analytical skills and high level of expertise using advanced Microsoft Office Excel and data base tools. Excellent interpersonal skills, including the ability to work and communicate effectively and appropriately with a diverse group of colleagues at all levels of the company, as well as the ability to distill complex issues into understandable language and present accurate information to other employees, peers, and superiors. Self-started with the ability to work effectively and efficiently with minimal supervision manage own time effectively, maintain control over all current projects/responsibilities and follow up on all relevant issues. Ability to adapt to job or organizational changes and/or readily accept new responsibilities and assignments. Work effectively with co-workers, internal and external customers and others by sharing ideas in a constructive and positive manner. Address problems and issues constructively to find mutually acceptable and practical business solutions.