Sanofi Group Risk Assessment, Audit & Field Monitoring, NA Ethics & Business Integrity in Bridgewater, New Jersey
The key responsibilities of this position are to support the execution of the Ethics & Business Integrity (Compliance) risk assessment process and execution of the audits identified in the risk assessment; support the execution of EBI monitoring activities underlying our Corporate Integrity Agreement (CIA) and other strategic activities as part of Sanofi’s overall approach to business monitoring. The role will also provide support of Independent Review Organization (IRO) activities associated with our CIA, and will report directly to the Head of CIA Mandated Monitoring & Reporting, NA Ethics & Business Integrity.
Specific activities include:
Support the operations and planning of Compliance Risk, Audit, and Field Monitoring activities and support other ongoing EBI business activities as requested.
Support the execution of EBI Audits identified through the CARE risk assessment process, including managing external audit partners.
Support the execution of the Compliance Assessment Risk Evaluation (CARE) process. This risk assessment is critical to identification of Compliance risk and mitigation strategies.
Support the execution of EBI field monitoring activities, including: Live monitoring by riding with Field Representatives, Live monitoring of Speaker Programs, Records review, Reporting documentation.
Support IRO engagement activities, including coordinating and facilitating information exchanges between Sanofi team and IRO representatives.
Coordinate with Internal Controls and Internal Audit functions regarding applicable controls, internal reviews and remedial action.
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.
6+ years of audit, monitoring, compliance, legal or regulatory experience in the pharmaceutical/healthcare industry
Auditing and monitoring experience in a pharmaceutical environment (Sales and Marketing) is preferred
IRO or Consent Decree experience 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 (Sales and Marketing) 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
This job has specific physical requirements (e.g. lifting, driving, ability to travel, etc.)
10%-20% travel (conditions permitting).
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.