Sr. Manager, Specialty Compliance Officer Innovative Medicine R&D

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Breda, Netherlands, Geel, Antwerp, Belgium, Leiden, Netherlands, Leiden, South Holland, Netherlands, Mechelen, Antwerp, Belgium

Job Description:

R-016624 Sr. Manager, Specialty Compliance Officer Innovative Medicine R&D

Location: Belgium or Netherlands

Contract: Full Time

Janssen Research & Development, L.L.C. is currently recruiting for a Sr. Manager, Specialty Compliance Officer, Innovative Medicine Research & Development in Europe.

Overall Purpose of this Job:

The Specialty Compliance Officer (CO) will support the Patient Engagement Strategy (PES) within Innovative Health Engagement & Advocacy and centers of excellence for Innovative Medicine R&D. The CO will provide directions related to strategy, oversight and verification of responsible areas to ensure an effective process is maintained as well as design and implement their Global Compliance Program. The CO is responsible for the review of patient/HCP/Investigator recruitment/retention/engagement materials created, and other day-to-day activities of the assigned areas. The CO is also responsible for the day-to-day oversight of the Compliance program, and the improvement and management of an effective global compliance program to support that business practices remain in compliance with all applicable regulations.

The responsibilities & the impact YOU will have:

• The CO provides review and approval of programs and processes with HCC and Regulatory.
• Advertising and Promotion (RAP) implications, being easily accessible to provide strategic guidance and direction; coordinates and provides guidance to ensure integration of HCC/RAP 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, or otherwise as directed by legal counsel.
• In consultation with the Director/Sr. Director, HCC, Privacy, and the Global Legal Organization, the CO 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 CO advises R&D management in responsible areas of potential compliance risk areas and recommends and implements appropriate action plans.
• The CO will formulate and facilitate 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/RAP environment.
• The CO will extensively support the cross-functional Compliance Review Committee (CRC) on a weekly basis. In addition, the CO will be responsible for compiling and reporting to Senior Leadership the Quarterly Risk Review (QRR) metrics for the PES organization.
• The CO 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 the CRC process.
• The CO will also collaborate with individual employees within all levels of the assigned therapeutic areas.

We would love to hear from YOU, if you have::

• A minimum of a Bachelors’ degree is required. A Masters’ degree is preferred.
• A minimum of 5 years of successful business experience in Regulatory Ad Promo, R&D, Medical Affairs, Health Care Compliance or a related area is required.
• A minimum of 3-5 years of experience with Clinical Trials and the R&D Process
• 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 preferred.
• Exceptional leadership skills, including the ability to proactively partner cross-functionally and lead meetings with Senior Leadership.
• 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 Regulatory Ad Promo, compliance programs, systems (e.g. RAMI, TriPod, iMR, VTMF, HighBond), 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.
• Travel up to 5% is required.