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Job Description:

Senior Health Care Compliance Specialist

Location: Romania

Full-Time - permanent contract

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.

PROFILE:

• Requires strong communication, organizational and analytical skills
• Proven track record in delivering results, self-starter and ability to manage complexity it is a must
• Industry related experience preferred, experience in the Pharmaceutical or Consumer industries
• Ability to work independently and in a detailed manner
• Ability to manage conflicts in an open and constructive manner
• Ability to work well between functions and across all levels of the business and effective time management skills are essential
• Understands the J& J Credo based culture and able to make things happen through managing a broad set of J& J Credo based values
• Background may include Compliance, Medical Affairs, Regulatory
• Fluent in English language

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.

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

COMMENTS:

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.