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
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.
- 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
- 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
- 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
- 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
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.
of 5 years of experience in pharmacovigilance case processing and/or PV
compliance monitoring is required
of GxP requirements is required
pharmacovigilance experience required with knowledge of global PV laws and
regulations is required
to function in a global matrix environment is preferred
communication and writing skills.
to lead global work streams, drive teams to make decisions, achieve
deliverables and manage and resolve issues independently
of and experience with multi-cultural working is preferred.
to evaluate processes and procedures against outcomes to identify methods to
improve efficiency, accuracy and compliance
to utilize appropriate initiative and autonomy in achieving objectives.
track record with negotiation and collaboration is required
experience developing and conducting presentations for different levels of
management; ability to tailor presentations to the appropriate level of detail
Janssen Research & Development, LLC. (6084)Job Function