Selina Feng, RAC

Prepare site regulatory documents, reviewing for completeness and accuracy Review, track and follow up the progress, the approval and execution of documents in line with project timelines Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information Prepare Publish submission-ready documents according to eCTD Modules for IND submission Build IND electronic submission package using Cunesoft Communicate with regulatory agencies, study site, and internal team coordinate the distribution and implementation of any forms. Prepare SAE safety report submission to the health authority Maintain and update Clinicaltrial.gov for all on-going studies Update ICF, Pharmacy Manual, and Laboratory Manual according to Protocol Amendment Generate Project Timeline using MS Project

Prepare and review documents for FDA submission of Phase III Oncology Studies Generate submission-ready documents using ISIToolBox Prepare, update and review Data Definition Documents (define.xml/pdf) using Adobe Acrobat, ISIToolBox and xml Prepare FDA's BIMO request of Summary Level Clinical Site Data Upload clinical study documents to Eisai internal EDGE system according to eCTD structure Build-up eCTD submission package with eCTDXPress Draft and update Analysis Data Reviewers Guide Update and review Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR) to support annual report for market/investigate products Attend meetings with biostatisticians, clinical operations and regulatory affair people to discuss submission related issues Involved in creating e-deliverables as per eCTD guidelines Accustom to work in tight deadlines and multiple studies simultaneously

Assist study planning, conducts and reporting of assigned studies Assist planning and organizing of project meetings Verify the quantity of investigational medications returned from clinical sites Review and analyze study data Review and monitor study database Reviews protocol deviations and major violations Identifies risks and escalate appropriately to line manager Prepare summaries of review findings Works in a cooperative manner with coworkers.

Responsibility: Participate in three-month training from each department, Medical Writing, Data Management, Biostatistics and Clinical Operation; Review SOPs for all departments and get training about GCP; Review Protocols, CRFs, Statistical Analysis Plans, Data Management Plans, Clinical Study Report and documents about Clinical Operations, such as Trial Master Files and so on; Review proposal, quotation and commercial agreements upon clients’ requests; Cooperate internal Operation Departments and customers to integrate proposals and study plans; Coordinate with investigators and sponsors to promote projects; Establish current customer database, maintains pipelines and other required system works; Do presentations to introduce company to potential clients; Coordinate with supervisors on other duties. Software used: SPSS, SAS, STAT

* Fundamental of Regulatory Affairs * Generics Regulatory Affairs in the US * Drug Discovery and Development * Drug Discovery through Preclinical Development * Fundamental of Intellectual Property * Communication and Leadership * Ethics in Clinical Research Biostatistics Statistics in Clinical Trial Molecular Biology and Biochemistry