Job Details

Description

Position Summary

The Compliance Specialist is responsible for supporting DEA Compliance activities for FFF Enterprises, Inc. (the “Company”) with a dedicated focus on Suspicious Order Monitoring (SOM). Specific responsibilities include supporting the implementation of DEA initiatives, training, investigation, auditing, monitoring, reporting and continuous improvement. This role also provides oversight and subject matter guidance to the Company and is responsible for maintaining compliance of federal, state, and all local laws, regulations and guidance, including but not limited to DEA compliance. Other responsibilities include supporting the manager in setting standards for all functional groups that participate in activities involving controlled substances, anti-diversion initiatives and working closely with multiple departments within the Company for controlled substance projects to minimize risks associated with diversion.

This position will be based in our Flower Mound, TX facility and is a full-time, onsite position.

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:

• Actively monitor and assure compliance with applicable laws, regulations and guidance, including but not limited to, 21 U.S.C 801 et seq and 21 CFR 1300 to End.
• Ensure that all compliance policies, SOPs and practices meet or exceed regulatory requirements including timely incorporation of regulatory changes.
• Support customer vetting “know your customer” due diligence, gather and assess documentation, document, and conduct ongoing monitoring.
• Support Customer suspicious order monitoring (SOM) by objectively conducting SOM Questionnaire investigations and thoroughly gathering all factual documentation that presents an accurate accounting of the Customer.
• Investigate pended controlled substances orders - gathering, assessing documents, and documenting to present a clear and concise assessment of “know your customer”.
• Ensure Company is compliant with all record keeping at the site and enterprise levels.
• 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 SORS, ARCOS, loss & theft, state requirements, and inventory reports.
• Coordinate with regulatory affairs to ensure timely identification and implementation of new and amended laws, regulations and/or guidance.
• Support the Sr. Compliance Manager in auditing DEA Compliance activities.
• Support the Sr. Compliance Manager in implementation and management of DEA and other compliance training programs and other departments working with controlled substances as necessary.
• Support the Sr. Compliance Manager with regard to Drug Enforcement Administration Field Office interactions for all DEA related issues at designated sites and Boards of Pharmacy.
• Support inspections and investigations.
• Other DEA and non-DEA specific compliance related responsibilities as necessary.
• 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.

Qualifications

Education, Knowledge, Skills and Experience

Required Education:

• Bachelor’s Degree or four (4) years relevant 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 two (2) years [six (6) for non-degreed candidates] of experience in pharmaceutical or healthcare compliance.
• 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-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 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, 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 judgment when necessary. Must be proactive in finding solutions.

Direct Reports

No

EEO Statement

FFF Enterprises and Nufactor are an equal opportunity employer and prohibits discrimination and harassment based on the following characteristics: race, color, religion, national origin, physical or mental disability, gender, age (40 years and over) qualified veteran 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.