Ethan Chen Email & Phone Number

Silver Spring, Md, Us

Lead the mission critical Division of Data Management Service and Solution with 20 staff members. Manage annual budget of $25M. Oversee multiple contract task orders with more than 100 supporting contractors to process approximate 260,000 human pharmaceutical product submissions FDA received annually. Provide overall leadership to CDER in streamlining electronic and traditional submissions and delivering modernize solutions and capabilities to enable rapid adoption of emerging electronic data standards. Interact with applicants, sponsors and CDER personnel to provide accurate and timely guidance to Pharmaceutical industry on electronic submission issues. Direct master data management services and oversee records management program to support business operations across CDER.

Silver Spring, Md, Us

Worked as the lead of the Data Management and Business Intelligence Capability team (DMBICT) with 8 staff members with an annual budget of $34M, supervising multiple contract task orders with more than 100 contractors. Served as the CDER technical architect, being an expert in the field of information management and CDER business processes. Established and led core CDER strategic enterprise informatics capabilities: Master Data Management, Business Intelligence, and cloud-based Electronic Submission to support the human drug review process by transforming existing CDER stovepipe legacy IT systems into a holistic CDER Informatics solution.

Silver Spring, Md, Us

Led, oversaw and implemented multiple mission-critical master data management and business intelligence programs and projects across all CDER business domains, and provided execution support to maximize the values delivered by the programs and projects. As program/project manager, collaborated and leveraged resources, processes, and technologies in an effective way to achieve benefits across different programs, projects, and work streams. As Contracting Officer’s Representative (COR), provided acquisition support to help translate CDER and OBI strategic goals and business priorities into executable action plans.

Falls Church, Va, Us

Serve various roles as an IT specialist, such as Senior Data and Solution Architect, Senior Business Analyst and Project Manager. Lead the portfolio management process for the Life Science Product and Strategy group. Work with business areas, Enterprise Architecture (EA), IT Security and Infrastructure and Operation division in Northrop Grumman and major pharmaceutical and biotech companies, such as Johnson & Johnson, Sanofi-aventis, Bayer Healthcare, United Healthcare, etc. Develop multi-phase technical implementation plan in supporting business process improvement within next 3 to 5 years. Manage multi-million dollar projects successfully through all phases of the Solution Development Life Cycle. Provide budget analysis, resource planning, and coordination of activities among client and company personnel. Monitor and control cost of project from initiation through completion to meet revenue and cost projections. Oversee and collaborate deployment in the global environment. The solutions have been successfully delivered with high custom satisfaction. Examples of such systems are e.Submission solution development, Sanofi-aventis NIS Development, CRF WorkManager Development, Migration and Deployment for various pharmaceutical, biotech and life science companies.

Managed information systems operations and personnel. Streamlined IS operations in alignment with the business objectives of the organization. Ensured the smooth operation of information technology related functionality throughout the firm. Transformed a traditional retail business into an efficient operation supported by the state-of-art information technology infrastructure.

Developed cost estimating, analysis, project schedules and plans for various construction projects, including Smithsonian Holocaust Museum, Hershey Chocolate World renovation, NYC Williamsburg Bridge renovation, various highways, schools, courthouses and buildings. Provided administration and development supports to the MIS activities.

Mba, Business Administration

M.S.E, Computer Application And Integrated Systems

B.S., Naval Architecture And Ocean Engineering