Lead Specialist, Healthcare Compliance

Johnson & Johnson Medical India

SUMMARY:

Implements the Health Care Compliance (HCC) program locally under supervision of the HCCO medical India to ensure business practices and activities are in compliance with related J& J internal guidelines, local laws and regulations and anti-corruption laws including the Foreign Corrupt Practices Act. Serves as a strategic business partner for local management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day-to-day business.

PROFILE:

• Position reports into the Associated Director, HCC, J& J MedTech India
• Requires strong communication, organizational and analytical skills.
• Broad business experience and ability to influence business decisions and business partners.
• Ability to understand business situations and propose solutions.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• The Lead Specialist will ensure that the HCC program effectively prevents and/or detects violations of law, regulations, J& J policies, including the Health Care Business Integrity Guide (HCBI), Prevention of Corruption Act, NMC - National Medical Council Guidelines (Formerly MCI - Medical Council Of India) and UCMPMD - Uniform Code for Marketing Practices in Medical Devices issued by Department of Pharmaceuticals in respective partnering franchises and/or departments.
• Partnering with franchise and/or department leadership team to ensure compliance ownership and right tone at the top.
• Support ethical decision-making within the business by participating in franchise and / or department leadership team meeting, reviewing promotional strategies and other significant business initiatives.
• Ensure business activities with Health Care Professionals (HCPs) / Government Officials (GOs) are planned in consistence with applicable HCC policies and procedures by reviewing and pre-approving those activities.
• Acting as a consultant by providing day-to-day guidance and advice to covered employees & the Professional education team.
• Deploy HCC policies and/or procedures in the covered franchise and/or department by providing necessary training and/or communication to covered employees, managing changes, and monitoring implementation.
• Implementing and following up on the Management Action Plan and guiding the business partners to close gaps and implement corrective actions.
• Implementing the escalation process for serious allegations, as appropriate.
• Stimulating and contributing to innovative approaches towards HCP’s and GOs which are consistent with the HCC/HCBI guidelines and framework.
• Conduct monitoring activities and investigations as required.
• Providing metrics as required
• Support risk assessment process.
• Support third party intermediary due diligence process (TPI-DD)
• Interface with legal counsel regarding HCC requirements and interpretation.