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Senior Compliance Counsel, U.s. Biopharma
Refer job# CDER153094
 
Senior Compliance Counsel, U.S. Biopharma Duties: 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. Act as effective ambassador to Business leaders and their teams to ensure appropriate focus on each of the elements of effective compliance in accordance with DOJ's recent issuance of its guidance, Evaluation of Corporate Compliance Programs . Ensure that all U.S. business unit colleagues covered under the current Corporate Integrity Agreement (CIA) understand and fulfill their obligations under the agreement. Partner with BU leadership to strategically assess potential risks associated with innovative new initiatives and develop appropriate controls, training, guidance or monitoring to ensure compliant execution. 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. Lead 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 trainings 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). Collaborate with Training team and Business to develop novel, impactful training solutions by identifying key unmet needs and leveraging non-traditional platforms (podcasts, bots, role-specific modules, AI technology). Provide risk identification and mitigation support to the therapeutic group throughout the business operation plan cycle recognizing that the Company's current go-to market model is increasingly complex with more customer-facing roles, novel business activities, and non-traditional engagements than previously needed and undertaken. Understand, assess and be able to provide guidance beyond traditional product promotional considerations including market access, coverage and reimbursement, patient portals & hubs, specialty pharmacies, account management and real-world evidence, particularly as it relates to specialty medications. 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, etc.). Understand, coordinate, and provide essential business-oriented risk and strategic input for U.S. proactive monitoring efforts; guide focal areas for effectively tailored and high yield reviews; 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; co-lead determination of critical emerging risks for priority inclusion in activities segment (patient and patient association engagements, account management activities, pre-launch considerations, etc.); drive agreed upon mitigations with the Business. Coordinate with key stakeholders in preparation of annual needs assessments (e.g., 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. Empower customer-facing colleagues to enhance ownership of Company's Compliance Champions Network to ensure that its potential for real-time, authentic ownership of integrity is realized. 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. Spearhead above BU projects with U.S.-enterprise wide application in areas of emerging environmental or cultural risk (e.g., patient support & engagement, pre-launch activities, novel field & customer-facing roles, external funding). Minimize compliance risks associated with third party transactions, as relevant, through effective due diligence and compliance program integration.

Qualifications: Excellent academic qualifications. Admission to practice law in the U.S., EU or other major market. Proven capabilities including 10+ 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. Proven senior-level strategic assessment capabilities and maturity to appropriately challenge/coach up to senior commercial and other functional leaders. Detail-oriented and strong organizational, analytical and creative thinking ability. Change agile, fluid, poised and measured in high pressure, demanding situations. Polished communications and presentation skills and executive presence. Strong business sense and understanding of the evolving business model and innovative thinker. Demonstrated strength in leadership, judgment and initiative. Proven capabilities to set priorities, drive results, and act efficiently and effectively within a complex business and organizational environment. Ability to manage multiple high-profile projects simultaneously with demanding internal stakeholders. Strong technical skills. Deadline: November 18, 2020
 
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