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Regulatory Affairs Associate - CSMP

Posted Mar 06
Full Time
On Site
Shepherdsville, Kentucky
Position Summary (Purpose of job):

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.

At CoverMyMeds, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at CoverMyMeds, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at CoverMyMeds. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. 

Our Base Pay Range for this position

$22.23 - $37.05

CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Qualified applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability or veteran status.​

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