Excellent work ethics and dedicated worker, with willingness to get the job done. Excellent people skills and communicator. Strong background which covers the full spectrum of regulatory/clinical monitoring from start up to close-out operational functions. Within each of these functions I have endeavored and for the most part successfully instituted a “common sense approach” to regulatory and clinical drug development globally.

Highlights:

• quality
• leadership
• Auditing
• regulatory affairs
• FDA and ICH
• Management
• Inventory
• Documentation
• Integrate
• SOPs
• Contractor for Clinical Trials
• gcp
• pharmaceutical
• clinical
• ich
• trial