JOB DESCRIPTION
Bachelors degree with 10+ years business experience to include 5+ years of Management experience Experience in developing, managing, and leading a compliance auditing or monitoring function, preferably in the biotechnology or pharmaceutical industry. Preferred Qualifications: Advanced degree preferred Experience leading teams, prioritizing, resolving conflicts, meeting deadlines, and following through on assignments. Experience with Microsoft Excel, Word, PowerPoint, and databases. Experience developing spreadsheets, analyzing data, demonstrating quality presentation skills including large and small audiences and at all levels of the organization. Must be able to work in a fast pace, high pressure and demanding environment. Knowledge of PhRMA Code, HIPAA Guidelines, and Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, relevant legal statutes and regulations including the False Claims Act and Anti-Kickback statutes, and corporate integrity agreements.? U.S. Healthcare Compliance, Director, Monitoring The U.S. Healthcare Compliance Department oversees the proper design, implementation, and monitoring of the Compliance Program. The Compliance Department's primary objectives are to ensure that the necessary Compliance Program elements are in place and functioning as intended to achieve effective compliance with internal standards, policies and procedures and external laws, regulations and requirements. The Monitoring Department will work closely with other functional areas to establish and maintain a risk based monitoring plan and schedule for systemic review of identified risk areas through data collection; trend analysis; measuring results to policies and procedures, laws, regulations, and recent enforcement actions. The Compliance Department intends to build a highly qualified and motivated team of professionals who will bring high levels of integrity, respect, experience, talent, perseverance, intelligence, creativity, energy and passion to become effective leaders within the company to position the company as a national leader in the field of Compliance within the pharmaceutical industry. Among the many functions and responsibilities of the Director of Monitoring will be managing a team of individuals who prepare regular and periodic summary reports relating to the operations of the company related to interactions with Healthcare Professionals. Key activities this person will be responsible for will include making key strategic decisions regarding appropriate monitoring plans for key risk areas; conducting internal team meetings with leaders in the Research and Development and Commercial departments to secure cooperation and engagement on monitoring activities; developing and reviewing monitoring plans with cross-functional teams within the company; and reviewing monitoring findings and working cross functionally to build support for appropriate remediation activities. Key relationships outside of the compliance department this individual will be expected to cultivate will include Research and Development, Global Commercial Operations, Law, and other functions in the company as needed. ?