Associate Director, Medical Safety Surveillance (Bloomington,IL) - (Bloomington, IL)

Directs, influences, implements and communicates case processing and reporting policy and direction for Global Product Safety. Evaluates new regulations and guidelines, develops plans and processes for implementation Communicates and coordinates across functional and global boundaries to ensure timely completion of AE cases for regulatory submission. Identifies, evaluates, develops and implements Global Products Safety policies, processes and system improvements. Manages department budgets and projects future financial and resource needs Identifies and anticipates potential department problems impacting the expertise to meet regulatory requirements and business goals, develops and implements methods of improvement and resolution. Manages the audit process, prepares responses and develops associated improvement plans (e.g. FDA meetings; responses to warning letters) Works cross-divisionally to influence business processes which impact product safety.