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Bu Compliance Counsel
Refer job# HEJW145762
BU Compliance Counsel The candidate will report to the North America Compliance Lead and will have a close working relationship with the therapeutic groups Global Compliance Lead and Chief Counsel to ensure alignment and consistency of the U.S. compliance program with that of the culture and vision of the global business unit. The role requires effective partnership with other Compliance and non-compliance functions to ensure continued management of historical U.S. healthcare focus areas while also enhancing abilities and tools designed to better identify, communicate, and advise on emerging risks in a rapidly evolving business environment. Manage and engage in proactive U.S. compliance activities including: (1) identification, assessment and mitigation of risk; (2) implementation of corporate and divisional policies and procedures within the therapeutic group and support of the development of business unit-specific guidance or policies as needed; (3) updating of compliance-oriented policies and procedures; (4) development and/or execution of training curriculum and program in key areas; (5) anticipation of emerging trends and changes to the political, legal, and regulatory landscape by working with the business and additional supporting colleagues; and (6) proactive development of tools to drive compliance and enhance compliance culture within the North America business unit. Ensure that all U.S. business unit colleagues covered under the current Corporate Integrity Agreement (CIA) understand and fulfill their obligations under the agreement. Examine current levels of support, policies, practices and other controls periodically with an eye towards simplification, efficiency, appropriate ownership and risk mitigation. Work closely with other U.S. business unit compliance colleagues to ensure consistency and leverage best practices across all therapeutic groups. Assist with preparation and delivery of quarterly Compliance Committee and/or Certification meetings, in consultation with the Global BU Compliance Lead, including updating business unit leadership on any on-going environment and government investigations and ensuring execution of relevant U.S. action items. Cultivate awareness and adaptation of QMS principles of leadership accountability in each of the areas of an effective compliance program with senior BU colleagues. Oversee relevant leader CIA compliance certification process including analysis of corresponding dashboard metrics and reports and overview with management certifiers. Develop and deliver compliance-oriented training for relevant U.S. colleagues (on-boarding, POAs & other sales meetings, leadership meetings) with particular focus on field-facing roles (sales, account management, field medical) and newer patient support roles (field reimbursement managers, patient affairs liaisons, nurse educators). Provide risk identification and mitigation support to the therapeutic group throughout the business operation plan cycle. Partner with business unit leaders to assist with key compliance-oriented communications throughout the business year (year-beginning, town halls, year-end, performance updates, product launches). Understand, coordinate, and provide support for U.S. proactive monitoring efforts; assist with remediation, training and corrective actions. Support the Risk Assessment Office with annual U.S. Risk Assessment process for review of both products and activities. Coordinate with key stakeholders in preparation of annual needs assessments (speaker program needs assessments) and other compliance related controls. Consult with Compliance Investigations team on management of potential investigative issues; assist with remediation and corrective actions including training and managerial support. Work with Compliance Investigations group and as appropriate Government Investigations to manage and understand any active compliance investigations, communicate findings to leadership, and facilitate appropriate remediation. Coordinate with various operational functions to help ensure effective monitoring and guidance to detect and mitigate compliance risks across more recurring activities; conduct observational field visits and support speaker program audit process. Align with Global Commercial Operations and business management on compliant structure and execution of incentive compensation & sales performance contests. Spearheading above BU projects with U.S.-enterprise wide application in areas of emerging environmental or cultural risk (patient support and engagement, pre-launch activities, novel field & customer-facing roles, external funding).

A J.D. Required. Must have excellent academic qualifications. Must have admission to practice law in the U.S., EU or other major market. Should have proven capabilities including 8+ years of experience in some or all of the following areas: healthcare law and policy, regulatory law, healthcare compliance, FCPA, managed markets, antitrust, litigation or other commercial legal or transactions practice, and intellectual property. Must be detail-oriented and strong organizational, analytical and creative thinking ability Should preferably demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Last Date to Apply for Job: September 16, 2019.
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