Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. Key...

This individual will be the representative for assigned project(s) (i.e., INDs, IND amendments, annual reports, FDA meeting packages, NDAs, NDA amendments, etc.) He/she will functions as a Project Manager, working with other departmental and...