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

SUMMARY:

The Health Care Compliance Senior Specialist supports Health Care Compliance Programs to ensure business practices and activities are in compliance with related Johnson & Johnson internal guidelines, local laws and regulations and anticorruption laws, including the Foreign Corrupt Practices act.
Therefore, the candidate supports planning, trainings, assessments, testing & monitoring and other varied Health Care Compliance functions.
This position reports directly to the Health Care Compliance Officer. Position is located in Bucharest and supports the Health Care Compliance Program in Romania.

EDUCATION AND EXPERIENCE:

• Bachelor degree
• Minimum of 3-4 years business experience
• Preferably experience in Compliance but also Medical Affairs, Regulatory Affairs is welcomed
• Knowledge of laws, regulations and industry standards of the Romanian Pharmaceutical market will be an asset

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Health Care Compliance Senior Specialist will work with Health Care Compliance Officer (HCCO) - to implement the company’s compliance program on various activities, which may include but not limited to the following:

• Assist HCCO in the update and implementation of all HCC policies (SOPs) and procedures on an ongoing basis.
• Support the HCCO in the implementation of education, training, and regular communications in compliance to all covered employees, including local sales, marketing, medical affairs, finance, HR, supply chain at the local level.
• Prepare the report of unplanned deviations, consolidate data & metrics relevant to Risk Assessment process and support HCCO in managing day-to-day inquiries, allegations, and investigations.
• Support HCCO to implement the escalation process for serious allegations, as appropriate.
• Support HCCO in developing and implementing country Testing & Monitoring Plan to demonstrate that the HCC program is effective; participate in execution where appropriate and engage Management Team accountability in the roll out.
• Prepare the Quarterly Monitoring Reports shared with the HCC committee and the MSM HCCO
• Execute a live monitoring plan on Johnson & Johnson Innovative Medicine’s activities, including monitoring in systems (QlickSense, iConnect, Concur) and live monitoring.
• Assisting in the implementing and following up on the Management Action Plan as assigned by HCCO.
• Actively participate and contribute to the HCC Cross-Sector Cooperation and contribute to cross-sector alignment.
• Assist HCCO in the update and implementation of all HCC policies (SOPs) and procedures on an ongoing basis.
• Serve as the first line of communication to the business for reviewing local requests and documentation.
• Support the HCCO in the administration of the HCC Committee meetings to ensure appropriate minutes and communication
• Collect and provide metrics to the HCC Officer and Operations group as assigned.
• Implementation and translation of global strategies into local level and sector level, based on appropriate local needs, goals and objectives, considering the local legislation, ARPIM codes and the external regulatory trends and environment
• Support Business Owners in the TPI management process – Due Diligence process in terms of follow up on questionnaires, certification, TPI training by respecting the deadlines.