As the Risk Management and Monitoring Analytics Director, you will:
• Drive and execute the Pharmaceutical global monitoring strategy and governance, interfacing and aligning cross sector and with HCC&P Operations, including the data analytics team, the external reporting team and the global transparency management team. In the US, the Director will plan and execute the Pharmaceutical Group US monitoring plan based on risk assessment and the requirements of the corporate integrity agreement, managing the US-based monitoring team. Globally, the Director will work with the Regional Sector Leads to develop and manage a monitoring plan based on risk assessment and assist the Regional Sector Leads with implementation.
• Work with HCCOs and business partners to enhance business processes based on monitoring results, effectively integrating compliance into the day to day business activities and enabling increased business ownership of activities with compliance risk.
• Be accountable to interface with HCC&P Investigations team, to drive consistent process to track and learn from investigations, with focus on those that result from monitoring, and provide data to HCCOs to drive business ownership of corrective and disciplinary action where applicable.
• Support periodic risk assessment and mitigation activities and reporting to relevant leaders regarding trends and recommended actions
• Support applicable requirements of Corporate Integrity Agreement(s), Open Payments or other external obligations through collaboration with relevant HCC&P teams, including global operations and training teams.
• Manage a Monitoring Senior Manager, two Managers and a Monitoring Analyst.
• Create a regulatory monitoring and oversight program for the J&J Pharmaceutical Group, focused on regulatory compliance risks, primarily in the US (see below) and in collaboration with the Regulatory Advertising and Promotion Group Director.
• Design and implement an effective compliance program focused on regulatory compliance risks across the Pharmaceutical Group, integrated and harmonized with the commercial and R&D compliance programs. This program will cross both commercial and non-commercial activities, and require interfacing with HCCOs across all of the North America Region, who provide guidance, policy interpretations and recommendations related to these risk areas for their business units and functions.
• Work with regional sector leads and HCCO North America to develop risk assessment and mitigation strategy for the pharmaceutical sector
• Project manage pharmaceutical sector HCC projects at the global or regional level that are primarily business facing, including projects coming out of risk assessment and audits.
• Work with the Pharmaceutical sector HCCOs to ensure effectiveness and timely completion of MAP items.
• A minimum of a Bachelor’s degree is required; accounting, finance or business-related areas of study are preferred.
• A minimum of 8 years of related business experience.
• A minimum of 5 years of experience within the Pharmaceutical, Medical Device and/or Health Care industry is required.
• Experience in health care compliance, auditing and/or monitoring, regulatory affairs or regulatory compliance, finance or other compliance related field is preferred.
• Experience working in a matrix environment is required.
• Project management experience is preferred.
• Knowledge of: (1) anti-kickback and false claims laws; (2) laws and regulations governing federal and state contracting and pricing programs; and (3) Affordable Care Act and impact on health care industry; are all required.
• Knowledge of commercial sales and marketing practices for healthcare products and services and the compliance risks preferred.
• Strong cross company/sector collaboration and change management skills, organizational, process and interpersonal skills are required.
• Must have strong written and verbal communication skills, organizational skills, and analytical skills.
• Broad business experience and a proven ability to influence business decisions and business partners are required.
• Proven track record in delivering results, self-starter and ability to manage complexity are required.
• Ability to deal well with ambiguity and new areas is required.
• Must be able to travel up to 25% of the time to domestic and international destinations.
Requisition ID: 4535180130