Johnson & Johnson Careers

Manager, Controlled Substance Compliance

Somerset, New Jersey
Compliance


Job Description

Requisition ID: 0205180118

Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Controlled Substance Compliance. The position will be based in Franklin, New Jersey.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  

 

The Manager, Controlled Substance Compliance directs and coordinates DEA regulatory compliance for the JOM Distribution centers. This individual will develop programs to assure DEA Regulatory compliance and ultimately is accountable for JOM’s systems and procedures to maintain the required closed system of controlled substance distribution, including:  DEA and State registration license renewals, import/export permit request submissions, DEA ARCOS reporting and State-mandated reporting, suspicious order monitoring, comprehensive recordkeeping, complete and accurate year end physical inventory counts, inventory reconciliation, discrepancy investigations, and DEA Close of Business Reports.

 

In this role, you will have leadership responsibilities for all DEA and State agency inspections.  You will be the main JOM contact with DEA Washington, DC for escalating issues relating to import/export permits, and certificates of registration.

 

Responsibilities include the following, while other duties may be assigned.

 
  • Provides expertise and guidance in interpreting agency regulations, guidelines, and internal requirements to ensure site compliance.
  • Implements CSC Standards locally, perform Gap assessment, develop action plan and monitor to completion.
  • Responsible for development and execution of site DEA inspection readiness plans. Support sites with managing local DEA district visits and correspondences.
  • Manage CS inspections and acts as main point of contact for HA during inspection
  • Execute reconciliation of all CS material including the investigation, destruction, and reporting of losses
  • Responsible for investigating all CS related deviations (loss in transit, complaints, etc.), identifying corrective actions, assigning owners, and monitoring for completion.
  • Ensure CSC training is performed at site for all impacted employees that handle CS.
  • Ensure required CS government record keeping and reporting is completed per regulations.



Qualifications
  • A minimum of a Bachelor Degree is required. Advanced degree is preferred.
  • A minimum 8 years of related working experience is required.
  • A minimum of one year of experience hosting regulatory inspections is required.
  • Experience working with popular ERP systems (i.e. SAP, JDE, MAPICS, etc.) is required. 
  • Experience working with EDI data (852, 867), IMS data and Sales data is preferred.
  • Experience interpreting compliance requirements and regulations is required.    
  • Knowledge of DEA and state regulations pertaining to shipping controlled substances preferred.
  • General knowledge of the pharmaceutical industry, brand and/or generics is preferred. 
  • General knowledge of DEA requirements as they relate to distribution and SOM is preferred.
  • This position may require up to 25% domestic and international travel including some overnights and weekends.
 

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.

 

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United States-New Jersey-Somerset
Organization
JOM Pharmaceutical Services, Inc. (6162)
Job Function
Compliance
Requisition ID
0205180118