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, specialty pharmacy, and inventory management solutions, with a dedicated focus on corporate compliance and licensing. Specific responsibilities include support for the implementation of Corporate Compliance initiatives, training, investigation, auditing, monitoring, reporting and continuous improvement.
This role is a full-time hybrid role requiring 2-3 days onsite at a company facility.
Essential Functions and Duties
Continuously strive to maintain full compliance and service quality to internal and external customers, and employee relations through the following activities:
- Proactively monitor, assess, and ensure compliance with all applicable federal and state laws, regulations, including but not limited to, the antibribery and corruption laws, Drug Enforcement Administration and state equivalents, healthcare fraud and abuse laws, Department of Health and Human Services, state Boards of Pharmacy, the Stark law, U.S. False Claims Act, U.S. Federal Anti-Kickback Statute, and U.S. Food and Drug Administration.
- Coordinate with key stakeholders to ensure timely identification and implementation of new and amended laws and regulations.
- Create, implement and update necessary policies and procedures specific to the Company to ensure regulatory consistency with all federal and state laws and regulations specific to wholesale distribution and operations.
- Lead compliance with the Physician Payment Sunshine Act, including the collection and review of transactions, preparation and filing of annual report, and updating of guidance to the Company regarding regulations.
- Primary responsibility for establishing and maintaining supplier and customer vetting process and documentation as well as ongoing monitoring.
- Oversee Company compliance with all record keeping requirements at the site and enterprise levels by coordinating with department points of contact and serving as subject-matter expert.
- Lead implementation of preventive and corrective actions to mitigate risk, including training and education, process improvements, and policy updates, as well as identifying opportunities for monitoring and self-auditing, designing and implementing processes, preparing reports regarding findings and proposing corrective action.
- Support the Chief Compliance Officer and other members of the Compliance team in the implementation and management of enterprise-wide compliance program activities and licensing compliance program; development and implementation of internal compliance metrics, audits and reports, including reporting to the Corporate Compliance Committee.
- Manage the on-going application and renewal of all State Licenses critical to FFF’s distribution center operations in California, North Carolina and Texas, as well as other locations as applicable.
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.
- Other duties as assigned.
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 applicable federal, state, and local laws and regulations, business administration, accountancy, sales, marketing, human relations, distribution, supplier management and procurement.
Preferred Knowledge:
- Knowledge of and experience with pharmaceutical manufacturing, pharmacy, distribution practices and systems and pharmacy distribution helpful.
Required Experience:
- Must have prior experience supporting or performing program management for large to mid-size entity 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 regulatory frameworks or similar.
- Previous experience managing and/or providing regulatory oversight.
- Demonstrated experience supporting regulatory compliance function.
- Minimum of five (5) years [nine (9) for non-degreed candidates] of experience in pharmaceutical, healthcare, or corporate compliance.
- Prior experience in a managerial position.
Preferred Experience:
- Experience with policy creation and management, as well as conducting investigations preferred.
- Experience conducting compliance audits preferred.
Required Skills:
- Exceptional regulatory acumen, analytical skills and high level of expertise using advanced Microsoft Office Excel and database 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-starter 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.
- Address problems and issues constructively to find mutually acceptable and practical business solutions.
Physical requirements
Vision, hearing, speech, movements requiring the use of wrists, hands and/or fingers. Must have the ability to view a computer screen for long periods and the ability to sit for extended periods. Must have the ability to work the hours and days required to complete the essential functions of the position, as scheduled. The employee occasionally lifts up to 20 lbs. and occasionally kneels and bends.
Must have the ability to travel occasionally. Working conditions include normal office setting/warehouse.
Mental Demands
Learning, thinking, concentrating and the ability to work under pressure, particularly during busy times. Must be able to pay close attention to detail and be able to work as a member of a team to ensure excellent customer service. Must have the ability to interact effectively with co-workers and customers, and exercise self-control and diplomacy in customer and employee relations’ situations. Must have the ability to exercise discretion as well as appropriate judgment when necessary. Must be proactive in finding solutions. Must be able to manage own time effectively and proactively address issues without constant follow-up from others.
Direct Reports
Potentially
FFF Enterprises/ NuFactor is an equal opportunity employer to all and prohibits discrimination and harassment based on the following characteristics: race, color, caste, religion, religious creed (including religious dress and grooming practices), national origin, ancestry, citizenship, physical or mental disability, medical condition (including cancer and genetic conditions), genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender, gender identity, gender expression, age (40 years and over), sexual orientation, veteran or military status, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or any state protected leaves), domestic violence victim status, political affiliation, reproductive health decision-making, and any other characteristic protected by state or federal anti-discrimination law covering employment. These categories are defined according to Government Code section 12920. The Company prohibits unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.
