Clinical Quality Assurance Auditor. Extensive knowledge of drug development, medical devices, local and overseas regulatory requirements including: IND, NDA and PMA submissions. Extensive knowledge with cGMP and cGCP
Very good research experience including genetics, pharmacology, cardiology and molecular biology.
Extensive experience of writing protocols, SOPs. CRFs. Data Entry Work Sheets (DEWS), IMPD, clinical management and monitoring and auditing in Israel, US and Europe.