Description
SUMMARY OF EXPERIENCE: Scientist with over 15 years in Clinical Research, and over 12 years in Global Regulatory Affairs with experience in CMC, Clinical (safety, efficacy), preparation of many CTA modules, direct agency interactions, labeling and Advertising & Promotion, preparation and maintenance of CCDS, PSUR and DSUR, system improvements and more. A leader with management of several direct reports, driving for results with experience in many therapeutic areas such as oncology, Rheumatology, neuroscience, renal, dyslipidemia, pain, and anesthesia. Over 15 years of experience in both marketed and in-development products.
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