Sr. Specialist, DEA Compliance-Onsite-5690

Job Title:      Sr. Specialist, DEA Compliance

Location:      Columbus, OH

Job Type:     Full time

Req ID:         5690

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Specialist, DEA Compliance to join our team.  In this role, you will be responsible for ensuring compliance to DEA regulatory requirements and confirming DEA systems, processes, and procedures are in place and properly managed to prevent non-compliance and mitigate risk.  Performing suspicious order monitoring (SOM) and customer due diligence review activities.  Responsible for DEA record keeping, annual DEA registration renewal, submission of DEA procurement quota, periodic controlled substance inventory, and submission of theft/loss reports.  This role must engage with all other functional areas and must network and leverage relationships locally, regionally, and globally as appropriate.  This role delivers results through execution of activities at all sites and interacts with individuals within the organization who have different personalities, styles, expectations, and motivations. 

 

Decision making can significantly impact compliance, including cost of non-conformance, potential regulatory citations, and fines.  This role has the authority to decline sales orders and to stop processes that are not in compliance with internal or regulatory requirements.  Decisions made can also set a precedent; therefore, critical assessment of all possible solutions is required to prevent unnecessary actions.  You will work closely with various individuals throughout the organization.  This role must communicate effectively to present succinct information and respond to inquiries; Interacts with individuals outside the organization, including regulatory inspectors, who have different personalities, styles, expectations, and motivations.  This role is encouraged to network and leverage relationships with professional organizations from outside the organization. 

 

 

Key Responsibilities:

• Executes Suspicious Order Monitoring (SOM) program activities including:
  • Analyzing controlled substance orders and SOM data for trends.
  • Investigating orders of interest and ensuring timely completion.
  • Making order release or cancellation recommendations based on investigation information.
  • Maintaining documentation for orders of interest.
  • Reporting suspicious orders to the DEA and applicable State Boards of Pharmacy.
  • Evaluating potential for diversion trends and making recommendations.
• Executes customer due diligence activities including:
  • Conducting controlled substance customer account set up due diligence reviews.
  • Assessing new and existing controlled substance customer due diligence SOM questionnaires.
  • Analyzing charge back reports or other data for trends.
  • Coordinating on-site visits of new and existing controlled substance customers.
• Supports cross-functional meetings to discuss periodic analyses and making recommendations to minimize risks associated with diversion potential.
• Executes and ensures controlled substance documentation complies with federal /state regulatory requirements and is maintained in an inspection-ready state.
• Performs internal DEA audits to ensure compliance with established procedures and regulatory requirements.  Obtains mutual agreements of CAPAs and facilitates to completion.
• Provides support with external DEA audits.
• Acts as subject matter expert for DEA inquiries, SOM/customer due diligence-focused systems / projects and provides training to new members of the organization.
• Maintains DEA registrations to ensure timely renewal.
• Maintains Power of Attorney documentation.
• Completes periodic controlled substance inventory.
• Prepares and submits theft/loss reports and verification requests in the defined timeframe.
• Prepares and submits DEA Quota
• Investigates DEA related matters