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FCW : June 15, 2015
A fellowship opportunity is currently available with the Office of Strategic Programs (OSP) within the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). The Risk-Based Quality Assessment & Inspections Fellowship project is administered by ORAU for the Oak Ridge Institute for Science and Education program. The objective of this research project is to transform drug quality review and inspection management processes by infusing modern risk-based regulatory approaches and tools in submission review, manufacturing facility assessment, and surveillance of marketed drugs and therapeutic biologics. The selected participant will support the implementation, expansion and evaluation of the informatics quality platform by utilizing methods from the fields of computer science, decision science and operations research. One specific area of focus is identifying means to improve data quality of a facility or process. The participant will apply modern tools for decision analysis, and visualization of big data and data management solutions to analyze research and develop the application to FDA’s regulatory review processes. Fellowship Opportunity • A Bachelor’s, Master’s or Doctoral degree in a computer science, health informatics, operations research or a related field received within the last five years. • Students currently pursuing a Master’s or Doctoral degree in the aforementioned fields at an accredited U.S . college or university are also encouraged to apply. • Demonstrated informatics and analytical skills and experience in analyzing and documenting complex processes are desired. To be considered, please send a current CV/resume to the attention of CDEROSPRecruitment@fda. hhs.gov and reference source code FDA15OBI009 in all communications. RBQA_ad.indd 1 5/1/15 10:44 AM June 15, 2015 FCW.COM 29 time when we need them the most. If those international relationships deteriorate, we run the risk of put- ting our country and our citizens in danger. Anderson: The game theo- ry of international coop- eration means that if we violate the rights of other countries by accessing the correspondence of their citizens, other countries may do the same to us. The U.S. must continue to set and adhere to high standards. Updating those regula- tions will allow us to preserve our alliances with other countries, which will, in turn, benefit law enforcement and individual privacy. Although we view aspects of the LEADS Act through different lenses, there is no doubt that the bill makes vital improvements to the law gov- erning access to personal correspon- dence. It strikes a balance between security and privacy that is critical today. We encourage Congress to pass the LEADS Act and enable the U.S. to set the example for other countries around the world. n Karen S. Evans is national director of the U.S. Cyber Challenge, a nation- wide talent search and skills develop- ment program focused on the cyber workforce. She served as administra- tor for e-government and IT at the Office of Management and Budget under President George W. Bush. Julie M. Anderson is a principal at AG Strategy Group. She previ- ously served as acting assistant secretary and deputy assistant secretary of policy and planning at the Department of Veterans Affairs under President Barack Obama. “We should continue to adhere to long- established international agreements in order to protect the rights of our citizens.” JULIE M. ANDERSON, AG STRATEGY GROUP 0615fcw_028-029.indd 29 5/22/15 12:41 PM
May 30, 2015
June 30, 2015