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ProfileDirector- Risk and Accountability Job The candidate oversees and provides strategic direction for the company. Risk Assessment and Mitigation Program (RAMP) and leads the Health Care Compliance Monitoring and Auditing group (HCC M&A). This role also performs special projects, assists in execution of Ethics and Compliance strategy and manages others. Reports to Senior Director, Risk and Accountability. Provides support to senior leadership and all other ethics and compliance functions. Works closely with in house legal counsel, global compliance colleagues and other business functions. External relationships include those with vendors, outside counsel, and industry peers. Manages a team of ethics and compliance professionals dedicated to health care compliance monitoring and auditing and risk identification and mitigation. Directly supports the Senior Director, Risk and Accountability with the execution of the Ethics and Compliance program, raising awareness of the program and fostering accountability for ethics and compliance throughout the organization. Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to compliance program, as appropriate. Participates in industry associations and events as appropriate to raise the profile of the Ethics and Compliance program and the company. Responsible for ensuring that Compliance senior management is informed of compliance issues in a timely manner while encouraging the flow of information between colleagues and line of business. Responsible for the development and implementation of comprehensive auditing and monitoring plans designed to mitigate risk and to ensure company functions/activities are in compliance with applicable laws regulations, industry codes and company policies while understanding local and global impact. Actively works to identify, analyze, and mitigate potential business ethics risks to the organization. Directly supports the Senior Director – Compliance in the coordination, implementation and strategic oversight of the HCC MandA group and the health care compliance risk assessment and mitigation program. Implements and provides strategic oversight of the health care compliance risk assessment and mitigation program by managing a team of Ethics and Compliance professionals to ensure the collection and review of relevant health care compliance information and data. Ensures close working relationships with senior leadership, line of business, and other Ethics and Compliance Department functions. Manages team of Ethics and Compliance professionals to ensure the robust monitoring and auditing of departments, functions, services, and vendors in satisfaction of government requirements and Ethics and Compliance program needs. Manages development and execution of RAMP to proactively assess and mitigate healthcare compliance risk across all company products, therapeutic areas and functional areas. Ensures that RAMP and the HCC M&A group support all functions within the Ethics and Compliance Department.
Qualification and Experience
A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred. Must have 12 years combined pharmaceutical, legal, regulatory, and compliance experience required OR 10 years’ experience required if accompanied by an advanced degree or certification (MBA, JD, PMP, etc.). Experience working under a CIA is preferred. Prior experience managing professionals required. Must demonstrates strong interpersonal skills and ability to influence at all levels of the organization. Should have demonstrated knowledge and clear understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements and other prosecution agreements with other pharmaceutical companies, PhRMA code and the current activities and developments involving pharmaceutical sales and marketing. Must have previous experience leading health care compliance monitoring and auditing efforts. Must have demonstrated knowledge and clear understanding of the required elements of effective compliance programs as outlined in the HHS OIG Compliance Program Guidance and the US Federal Sentencing Guidelines. Should have ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy. Must have the ability to think objectively and use sound reasoning principles. Must have proficiency in Microsoft Office Suite.N Should have advanced knowledge of health care compliance issues. Must have demonstrated ability to build and maintain effective strategic relationships and networks with internal and external stakeholders. Should have demonstrated ability to manage and lead change in a large, matrixed organization. Should demonstrates a thorough understanding of our business, industry, market trends, requirements, and the external environment while understanding impact.