Manager, Compliance Operations
Location:
Horsham , Pennsylvania
Posted:
January 05, 2017
Reference:
8846161021-en-us

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Manager of Compliance Operations to be based in Horsham, PA. Up to 5% travel is required.

 

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.  

 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.  

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

The Manager, Compliance Operations is responsible for oversight of compliance investigation processes associated with Individual Case Safety Reports (ICSRs) submitted late to Health Authorities or oversight of compliance investigations associated with inbound delays to GMS Operations from Alliance Partners or Janssen Local Operating Companies. The individual will also be responsible for responses from Janssen to Alliance Partners when compliance documentation is requested from Janssen.  Monitors case receipt compliance investigations associated with Local Operating Companies, ensures that they are completed within SOP timelines and that appropriate documentation is completed and retained. This person may be responsible for direct or indirect oversight of J&J employees and vendor resources.

 
Responsibilities:
  • Performs and/or manages complex compliance investigations related to Local Operating Companies, Vendors and Alliance Partners and other complex investigations as needed
  • Driving accuracy and consistency of compliance investigations and investigation categorizations
  • Provides input into corrective/preventative actions and effectiveness measures for CAPAs as appropriate
  • Collecting and analyzing compliance results, and sharing results with Janssen management, Alliance Partners and vendor compliance contacts
  • Works across functional areas to develop and implement strategies to drive compliance improvements. 
  • Keys for success in this role include the ability to develop collaborative partnerships with Alliance Partner and Local Operating Company colleagues of all levels and to influence without authority when complex issues or negotiations arise
  • Must have the ability to resolve complex issues independently and to determine when escalation to senior management is appropriate.
  • Ensuring quality of all documentation, driving process improvements and tracking, trending and presenting trends of late submission root causes
  • Provides input into corrective/preventative actions and effectiveness measures for late ICSR and Aggregate Report CAPAs and other compliance related CAPAs as appropriate
  • Works closely with Associate Director, Compliance Operations to implement strategies for compliance improvements
  • Interfaces directly with all functions impacting GMO / GMS monitored compliance metrics (including but not limited to): Case Management; Case Reporting; Vendor Compliance Points of Contact; PAC; IPV / LSO; LOC; QPPV; 3rd Party Compliance Contact; GRA; GCO


Qualifications
  • Minimum of Bachelor’s Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience OR advanced academic degree with 5 years of pharmaceutical industry experience.
  • Minimum of 5 years of experience in pharmacovigilance case processing and/or PV compliance monitoring is required
  • Understanding of GxP requirements is required
  • Global pharmacovigilance experience required with knowledge of global PV laws and regulations is required
  • Ability to function in a global matrix environment is preferred
  • Excellent communication and writing skills.
  • Ability to lead global work streams, drive teams to make decisions, achieve deliverables and manage and resolve issues independently
  • Understanding of and experience with multi-cultural working is preferred.
  • Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance
  • Ability to utilize appropriate initiative and autonomy in achieving objectives.
  • Excellent track record with negotiation and collaboration is required
  • Proven experience developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail is required


Primary Location
United States-Pennsylvania-Horsham
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Pharmacovigilance

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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