Director, DEA Compliance – Pharmaceutical/Healthcare Industry
Flower Mound, TX 75022
Job Purpose: The Director, DEA Compliance, is responsible for the management of DEA Compliance for all the company’s business units. The individual will report to the Chief Compliance Officer - responsibilities include implementation of DEA Compliance initiatives, training, investigation, auditing, monitoring, reporting and continuous improvement as well as serving as liaison with the local DEA Field Office and subject matter expert at the responsible site(s). Provides oversight and subject matter guidance to the organization and is directly responsible for, maintaining DEA compliance of federal, state, and all local laws, regulations and guidance. Other responsibilities include setting standards for all functional groups which participate in activities involving controlled substances, anti-diversion initiatives and working closely with multiple departments within the organization for controlled substance projects to minimize risks associated with diversion
** Please send resume for consideration and call Liz Valdez @ 888-513-9413 or 951-302-4750 ext. 411
JOB DESCRIPTION / 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, 21 U.S.C 801 et seq and 21 CFR 1300 to End, and applicable SOPs
- Ensures that all SOPs and compliance policies and practices meet or exceed regulatory requirements including timely incorporation of regulatory changes
- Supplier and customer vetting including “know your customer” process and documentation and ongoing monitoring
- Oversight of suspicious order monitoring (SOM) program by managing parameters, daily activities and ensuring proper documentation.
- Ensures organization is compliant with all record keeping at the site and enterprise levels.
- 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 records and reports are accurately completed and filed in accordance with DEA regulations
- Ensure all reporting is complete and comprehensive including 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.
- Responsible for the development and implementation of internal compliance metrics and reports, including reporting to the Corporate Compliance Committee
- Lead DEA training programs for direct reports and other departments working with controlled substances as necessary.
- Serve as company liaison with the Drug Enforcement Administration Field Office for all DEA related issues at designated sites and Boards of Pharmacy.
- Coordinate and reconcile biennial 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-related responsibilities as necessary
Salary Range and Bonus Potential: $120,000 – 160,000 per year
Benefits: (once hired perm)
- Medical & Dental Insurance
- Retirement Savings Plan 401(k)
- Paid Time Off (Float & Sick)
- Holiday Pay
- Life Insurance; LTD
Requires broad knowledge of DEA 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. Must have prior experience performing program management for large to mid-size corporation with projects that span considerations across people, processes, technology and external stakeholders.
Exceptional regulatory acumen, analytical skills and high level of expertise using advanced Microsoft Office Excel and data base tools.
- Requires broad training in fields such as business administration, federal and state regulatory requirements, accountancy, sales, marketing, computer sciences or similar vocations generally obtained through completion of an advanced degree, resulting in a master’s degree
- Previous experience leading and / or providing regulatory oversight
- Demonstrated experience leading DEA compliance and / or regulatory compliance function for a minimum of (5) years
- Previous experience interacting with external regulatory agencies including DEA office(s) and Investigators
- High level of experience with CSOS, SOM, and ARCOS systems
- Investigative and diversion control background preferred
- Requires a minimum of ten (10) years of experience in pharmaceutical industry in professional / executive roles or as a consultant
- A Bachelor’s Degree in Business Administration or similar field is required.