Compliance Audit and Risk Assessment Lead, NA EBI
Bridgewater, New Jersey
The key responsibilities of this position are to lead the execution of the Ethics & Business Integrity risk assessment process; direct the execution of the audits identified in the risk assessment; direct the execution of the Mandated Monitoring as outlined in our Corporate Integrity Agreement (CIA) and other strategic Monitoring activities as part of Sanofi’s overall approach to business monitoring. The role will also provide oversight and direction of Independent Review Organization (IRO) activities and will report directly into the Head of Monitoring and Compliance Investigations.
The person filling this position will be expected to operate independently, with limited oversight. This position will also involve other ad hoc requirements and projects as they arise.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Direct the execution of the Compliance Assessment Risk Evaluation (CARE). This risk assessment is outlined in the CIA and is critical to the IRO review and the identification of risk mitigation strategies for the top risks identified. Direct the execution of Compliance Audits identified through the CARE risk assessment, including managing external audit partners. Direct the execution of the CIA Mandated Monitoring Program which includes:
- Live monitoring by riding with Field Representatives
- Live monitoring of Speaker Programs
- Records review
- Providing reporting to business leaders
- Development of Annual Report to the OIG
Manage IRO engagement and activity:
- Coordinate with Monitoring Team to execute on IRO deliverables
- Review and approve the final IRO report for the Annual Report to the OIG
Assist with strategic monitoring activities, including continued enhancements to Compliance monitoring strategies and activities
- Coordinate with Internal Controls and Internal Audit functions regarding applicable controls, internal reviews, and remedial action
- Manage and control budget for mandated and other strategic monitoring activities
Support other Compliance activities as requested by the Head of Monitoring & Compliance Investigations and Head of North America Ethics & Business Integrity.
REQUIRED EDUCATIONAL BACKGROUND AND JOB-RELATED EXPERIENCE:
- Bachelor’s degree from an accredited four-year college or university
- Post-bachelor’s degree from an accredited college or university (e.g., Masters, MBA or equivalent)
- 15+ years of legal, regulatory, or compliance experience required; preferably in the pharmaceutical/healthcare industry
- Familiarity with Sales and Marketing functions and compliance principles related thereto is required
- Auditing and monitoring experience in a pharmaceutical environment (Sales and Marketing) is preferred
- IRO, Consent Degree and/or experience interacting directly with Government authorities preferred
- Experience working independently and effectively with cross-functional groups, such as Legal, Regulatory, Medical, Commercial, and R&D, as well as with affiliates in a shared service environment, while maintaining strict compliance with company policies and procedures
- Track record of establishing a trusted business partner relationship
- Significant knowledge and understanding of pharmaceutical compliance environment and requirements, including the Food, Drug, and Cosmetics Act, the False Claims Act, state and federal Anti-Kickback Statutes and the Foreign Corrupt Practices Act
- Proficient computer skills, including experience with MS programs is required; data mining skills are highly desirable
- Experience interacting with Senior Business Leaders
- Excellent communication, interpersonal, and writing skills and personal judgment
- Ability to work independently and exercise independent sound judgment
- Ability to advise and discuss complex matters with internal clients and potentially to third party vendors, as necessary
- Ability to develop, present, and follow through on innovative compliance solutions, while taking into account departmental objectives
- Knowledge of regulations and laws that impact pharmaceutical industry
- Maintains highest standards of ethics and integrity and respects confidentiality of sensitive matters
- Team player, ability to develop and leverage collaborative relationships with cross-functional teams; facilitate agreement across functional areas
- Ability to handle multiple responsibilities simultaneously and maintain a high quality and timeliness for all deliverables
- Ability to identify risks and execute practical action plans
- Handle tasks efficiently under pressure when circumstances dictate a sense of urgency
PHYSICAL REQUIREMENTS OF THE JOB:
This is a desk job with no specific physical requirements other than to use standard office equipment such as PC, telephone, email, fax, copy machine, etc.
This job requires extensive use of computer equipment (e.g., primary functions are to enter and retrieve data from a computer, software programming and development, etc.) Please specify:
This job has specific physical requirements (e.g. lifting, driving, ability to travel, etc.) Please specify: 15-20% travel
LEADERSHIP SUCCESS PROFILES & COMPANY VALUES:
Job requires consistent demonstration of appropriate behavioral competencies as defined through the company’s Leadership Success Profile and Company Values Model
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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