Senior Manager, DEA Compliance

Adare Pharma Solutions Recruiting Team•Vandalia, OH

10h•Onsite

About The Position

The Senior Manager DEA Compliance will implement and maintain policies; provide input into strategy, policies and practices for compliance with DEA Controlled Substance regulations, requirements, and expectations. The Senior Manager will also support development and execution of quota strategies based on current DEA regulations and practices in partnership with Procurement and the business forecasting teams. Reporting responsibilities such as ARCOS and ongoing DEA form submissions are also within the scope of this role, and a critical function in maintaining compliance with DEA guidelines.

Requirements

Bachelor's degree and 4 years of experience with DEA Compliance Regulations of controlled substances or equivalent combination of education, transferrable skills, and experience
Must possess knowledge and interpretation of DEA regulations and industry guidance’s, policies, and procedures pertaining to the DEA Controlled Substance and/or supply chain security.
Experience in facilitating and executing compliance training events.
Experience in facilitating a DEA Compliance work environment for production and distribution.
Ability to coordinate multiple group efforts within the company to achieve objectives.
Ability to perform computations such as percentages, ratios, and rates.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
Must possess organization skills, time management skills and attention to detail.
Proficient in Microsoft Office.
Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
Exceptional attention to detail and excellent organizational skills.

Nice To Haves

Ability to accommodate up to 10% travel.

Responsibilities

Understands and interprets DEA regulations and directs the development and implementation of policies, procedures, and practices for compliance with applicable rules and regulations.
Execute and operationalize strategies for obtaining and maintaining controlled substances quotas.
Provide DEA compliance training to facility staff.
Oversee and perform all ARCOS reporting on a monthly basis.
Monitor all licensing requirements regarding the handling of controlled material.
Oversee the applications, i.e. DEA250, for procurement quota.
Monitor the use of DEA222 order forms for compliance with DEA requirements.
Assess site security measures in accordance with DEA guidelines, make recommendations for improvement where needed
Review cGMP documentation related to controlled substances.
Oversees inventory accountability and reconciliation for controlled substances, including end-of-year reconciliation practices.
Coordination of controlled drugs destructions in accordance with DEA regulations.
Manages, executes, and supports audit program to confirm and proactively ensure compliance.
Leads and directs Anti-Diversion due diligence program to minimizes diversion potential through audits, training, security programs and investigations.
Remain current with industry practices/trends and regulatory agency expectations governing controlled substance handling and reporting, and supply chain security industry practices.
Manage controlled substance handling to ensure DEA regulation compliance.
Ensure proper security controls are in place for shipping and receiving controlled drugs.
Participates in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business.
Respects policies, procedures and regulations in force in the company.
Completes assigned tasks in a safe manner and in a constant state of alertness.
Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code
Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.
Other duties as assigned.