The 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. Specific responsibilities include support for the implementation of corporate compliance initiatives, training, investigation, auditing, monitoring, reporting and continuous improvement, as well as regulatory oversight of federal and state regulations applicable to the Company's business operations, including the ongoing application and renewal of all state licenses critical to operations.
Essential Functions and Duties
Continuously strive to maintain full compliance and service quality to internal and external customers, and employee relations through following the activities:
Actively monitor and assure compliance with applicable laws, regulations and guidance, including but not limited to, the federal Food, Drug, and Cosmetic Act, U.S. Federal Anti-Kickback Statute, U.S. False Claims Act, healthcare fraud and abuse laws, antibribery and corruption laws, the Stark law, Drug Supply Chain Security Act, Controlled Substances Act (21 U.S.C 801 et seq and 21 CFR 1300 to End, and applicable SOPs), HIPAA, and data privacy and security laws and regulations.
Create, implement and update necessary policies and procedures specific to FFF Operations to ensure regulatory consistency with all federal and states laws and regulations specific to wholesale distribution and operations.
Assist with 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.
Ensure 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.
Coordinate with regulatory affairs to ensure timely identification and implementation of new and amended laws, regulations and/or guidance, including all FDA regulations including, but not limited to, the Code of Federal Regulations, the Food Drug and Cosmetic Act, CBER regulations, PDMA regulations, DSCSA regulations; California Board of Pharmacy; North Carolina Department of Agriculture and Consumer Services; Texas Department of State Health Services; as well as all out of state board of pharmacy and department of health regulations applicable to FFF Enterprises' wholesale operations.
Support the Senior Director, Compliance and Chief Compliance Officer, in the implementation and management of enterprise-wide corporate compliance program activities; development and implementation of internal compliance metrics, audits and reports, including reporting to the Corporate Compliance Committee; implementation and management of DEA and other compliance training programs, as necessary.
Adheres specifically to all company policies and procedures, Federal and State regulations, and laws.
Display dedication to position responsibilities and achieve assigned goals and objectives.
Always represent the Company in a professional manner and appearance.
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.
Qualifications
Education, Knowledge, Skills, and Experience
Required Education:
Bachelor's Degree in a related field or four (4) years relevant experience in lieu of degree.
Required Knowledge:
Requires broad knowledge of drug wholesaler laws and regulations, applicable federal, state, and local laws, compliance, 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 Drug Distribution and/or Pharmacy laws and regulations, as well as state licensing helpful.
Required Experience:
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.
Minimum of ten (10) years [fourteen (14) for non-degreed candidates] combined experience in pharmaceutical, healthcare, or wholesaler compliance and/or licensing.
Preferred Experience:
Experience with Drug Distribution and/or Pharmacy laws and regulations, as well as state licensing helpful.
Experience implementing and/or managing corporate compliance is a plus.
Previous experience interacting with external regulatory agencies.
Required Skills:
Exceptional regulatory acumen, analytical skills and high level of expertise using advanced Microsoft Office Excel and database tools, as well as willingness to learn and adapt to using other technology tools to perform job functions.
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.
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 prolonged 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 to 20 lbs. and occasionally kneels and bends. Must have the ability to travel occasionally. Working condition include normal office setting.
Mental Demands
Learning, thinking, concentration 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 judgments when necessary. Must be proactive in finding solutions.
Direct Reports
No
EEO/AAP Statement
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.