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Director/Corporate Counsel - Promotional Monitoring Lead
Refer job# KOAU136741
 
Director/Corporate Counsel - Promotional Monitoring Lead The candidate will be responsible for developing and executing on a pliable, risk-based, and integrated monitoring strategy focused on promotional practices and related risks within the U.S. sales force. Will lead a team of monitoring specialists responsible for product promotion-related monitoring of the U.S. sales force (e.g., claims-based monitoring, speaker program monitoring, etc.). Will be responsible for: (i) conducting first and second-level reviews of structured and unstructured data, (ii) overseeing execution of all other product promotional reviews conducted by his/her team, (iii) assessing the CMA promotional monitoring portfolio and identifying potential risk-based enhancements, (iv) managing, troubleshooting and identifying opportunities to enhance the systems and processes that support U.S. CMA, and (v) overseeing the development and dissemination of the team s periodic reports. The U.S. Promotional Monitoring Lead also will be a part of a cross-functional team that is responsible for analyzing a variety of quantitative and qualitative data sources to identify compliance-related signals, issues, or trends relating to a broader range of compliance risks - the results of which will support more informed decision-making, action-planning, continuous improvement and risk mitigation across the enterprise. The role reports directly to the U.S. Compliance Monitoring and Analytics (US CMA) Lead, who oversees the full portfolio of U.S. Compliance monitoring activities. Work closely with colleagues within Compliance (BU Compliance, Risk Assessment, Investigations, and across the Global Programs and CMA portfolio), Commercial Finance, External Medical Communications, Strategy and Commercial Operations, and Legal. Work closely the U.S. CMA Lead and other cross-functional partners and internal stakeholders (incl. BU Compliance, Commercial Finance, Commercial Operations, Medical, and others) to ensure that the U.S. promotional monitoring strategy is part of an integrated, risk-based enterprise-wide approach to compliance monitoring in the U.S. Responsible for reviewing the CMA promotional monitoring portfolio on a continuous basis to identify potential risk-based enhancements, including opportunities to on-board and off-board reviews based on risk. Leading, or representing CMA in, cross-functional discussions and collaborations with a range of internal stakeholders, including Legal, BT, Finance, and Compliance. Conducting primary and secondary review and analysis of data sources to identify potential compliance issues and trends involving product promotion and related sales force activities. Developing the strategy for and overseeing execution of the U.S. Speaker Program Monitoring and Field-Ride Observation platforms, in partnership with BU Compliance and Commercial Operations, among others (incl. developing and executing a risk-based targeting approach, coordinating with internal and external monitors, and otherwise ensuring end-to-end program success). Directing and overseeing the day-to-day activities of the team s monitoring specialists, who will report to the U.S. Promotional Monitoring Lead and are responsible for the bulk of CMA s continuous and ad hoc monitoring efforts (in addition to conducting reviews, the team is responsible for timely and effective stakeholder communications / information sharing, escalation of potential issues, and report generation). Partnering with the U.S. CMA Lead to troubleshoot and identify opportunities to enhance the systems and processes that support the U.S. CMA team (incl. CMA s databases, technology, review platforms, etc.). Researching and ultimately understanding the nuanced risks - both existing and emerging - within the healthcare compliance space, particularly those involving promotional activities by our U.S. sales force (this includes subject-matter expertise in applicable U.S. healthcare laws and regulations, industry guidelines, product promotional strategies, clinical data for monitored products, etc.). Partnering with the CMA U.S. Lead and other CMA personnel to conduct in-depth compliance assessments - as well as continuous and ad hoc monitoring - of other risks and activities, including those outside of the promotional context, as needed. Coordinating with internal partners, clients and other stakeholders to ensure that program objectives are met in a timely manner. Working with, and occasionally directing the efforts of, outside counsel, vendors and consultants. Drafting memoranda documenting issues and trends identified in reviews or memorializing an approach, strategy, or process (job-aids, internal guidance documents, etc.).

The candidate must have excellent academic qualifications (J.D. and admission to practice law in the U.S. are preferred). Should have 8+ years of experience in the following areas: healthcare law and policy, regulatory law, healthcare compliance, litigation or other commercial legal or transactions, audit and / or monitoring, etc.
 
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