·Wrote 14 clinical study protocols for bioequivalence studies under various countries regulatory requirements
·Wrote one Phase I clinical protocol, one patient support study.
·Wrote clinical study reports for Phase II oncology trials and Pharmacokinetics study and 12 bioequivalence studies.
·Prepared essential documents for IRB and authorized agency submission including study synopses, informed consent forms, and response to reviewers.
·Performed other medical science related tasks including medical coding, safety reporting (to IRBs and local ADR center), case report form reviewing and clinical data reviewing.
·Performed medical related training for clinical operation team