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Position supports the Regulatory Manager as part of the Controlled Substance Monitoring Program by maintaining the control product compliance aspect such as Suspicions Order Monitoring System for controlled products (SOMs); Import/Export of Control Product; C2 Form/CSOS Completion; Maintaining missing control product notifications/forms; Product Verification; Customer Medi Audits; etc.

Key Responsibilities:

The core elements of the RxC CSMP are:

• Reviewing prospective Customers and determining whether a prospective Customer may be approved to receive controlled substances distributed by RxC.

• Reviewing Customers on an ongoing basis and, as appropriate, determining when a customer is no longer approved to receive controlled substances distributed by RxC.

• Establishing and maintaining order thresholds for approved Customers that limit the monthly quantity of controlled substances for each base code that Customers may order.

• Monitoring Customer’s orders for controlled substances to identify orders of interest in accordance with certain specified criteria.

• Investigating each order of interest and documenting RxC’s determination as to the disposition of the order, including whether to release or block the order; and Reporting to DEA and relevant state regulatory authority’s orders blocked under the CSMP as suspicious orders.

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

Business Experience –

• Prior Pharmaceutical industry experience within an operational or regulatory role regarding controlled substance products.

• Ability to communicate both verbally and via documentation
• Detail oriented
• Excellent problem-solving skills
• Strong work ethic/Dependability
• Professional in behavior and appearance
• Be able to work independently or with a cross team effort
• Analytical mind
• High School degree or equivalent experience
• Computer knowledge, fluent in Microsoft Office but able to learn other programs easily

Specialized Knowledge/Skills –

• Familiarity with CFRs, cGMPs and GDPs
• Action Oriented
• Drive for Results
• Adaptability
• Technology adaptive
• Strong writing skills
• Ability to lead intradepartmental groups and multiple teams 
• Knowledge of CFR 21 Part 1304 helpful

Working Conditions:

Environment (Office, warehouse, etc.) –

• Traditional office environment.
• Warehouse

Physical Requirements (Lifting, standing, etc.) –

• Large percent of time performing computer-based work is required.