Johnson & Johnson is recruiting for a Senior Manager, R&D Health Care Compliance Officer of Janssen Research & Development, L.L.C. located in Titusville, NJ with considerations in Raritan, NJ and Spring House, PA locations.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, and immunologic disorders.
The R&D Health Care Compliance Officer (HCCO) provides tactical direction and oversight of the global R&D Health Care Compliance (HCC) for the Biotechnology Center of Excellence, Infectious Disease, and Oncology and other areas as assigned.
- The HCCO is also responsible for the review of totality transactions, materials created, and other day-to-day activities of the assigned areas.
- The HCCO is responsible for the day-to-day maintenance of the HCC program, and the improvement and management of an effective global health care compliance program to assure that business practices remain in compliance with all applicable regulations.
- The HCCO provides review and approval of programs and processes with HCC implications, being easily accessible to provide strategic guidance and direction; coordinates and provides guidance to ensure integration of HCC into strategic plans and tactical execution; ensures accountability for compliance by problem identification, oversight, follow-up, and resolution to investigations generated by the Program, including investigations initiated for-cause, those based on anonymous reports of potential misconduct or otherwise as directed by legal counsel.
- In consultation with the Director/Sr. Director, HCC, Human Resources, and the Law Department, the HCCO helps ensure that there is a mechanism in place for disciplining instances of non-compliance (including the failure to prevent, detect, or report any non-compliance), appropriate to the nature and extent of the deviation, and ensure consistency in the application of disciplinary action.
- The HCCO advises R&D management of potential compliance risk areas and recommends and implements appropriate action plans. S/He formulates and facilitates education programs for all employees, agents, affiliated providers, or others working with the assigned areas when deemed appropriate; assesses the need for additional training and education; develops and delivers appropriate compliance trainings; anticipates potential problems and proactively takes appropriate steps; oversees the creation of appropriate tracking mechanisms based on problem identification; provides clarity around the ambiguities of the evolving HCC environment; assures that requirements of governmental settlements are implemented for assigned areas.
- The HCCO will be accountable for communicating company healthcare compliance standards to project owners and third party suppliers, and training and information updates on new laws and guidance, and will liaise with project owners to review materials and program concepts prior to submitting items into review process.
- The HCCO will also collaborate with individual employees within all levels of the assigned therapeutic areas.
- A minimum of a Bachelors' degree is required. A Masters' degree is preferred.
- A minimum of 5 years of successful business experience in R&D, Medical Affairs, compliance or a related area is required.
- Familiarity with HCBI/HCC/fraud and abuse laws, FDA and Foreign Corrupt Practices Act (FCPA) rules governing Health Care Professionals (HCP) interactions globally, privacy laws globally, and health authority rules is required.
- Exceptional written and verbal communication skills are essential, as well as a proven track record of creating change.
- Demonstrating ethical behavior in all situations and a strong understanding of the company's relationship with customers are required.
- Experience with global R&D or Medical Affairs, compliance programs, systems, procedures, and operations of R&D activities are strongly desired.
- Experience with overseeing the development and presentation of appropriate employee education and training programs including formal training and communications is preferred.
- Experience developing tools to assist end-users with processes and procedures related to HCC/HCBI is preferred.
- This position is located in Titusville, Raritan NJ or Spring House, PA and requires up to 5% travel. Are you willing and able to meet these requirements?
United States-New Jersey-TitusvilleOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-RaritanOrganization
Johnson & Johnson International (6078)Job Function
Health Care ComplianceRequisition ID