Loi Thanh Nguyen, 64Liberty, MS

Kindred Rehabilitation Hospital at Clear Lake Apr 2009 to 2000
Registered Respiratory Therapist Triumph Hospital at Clear lake - Webster, TX Oct 2008 to Aug 2009
Registered RegRespiratory Therapist University of Texas Medical Branch's John Sealy Hospital - Galveston, TX Aug 2007 to Aug 2008
Respiratory Therapist San Jacinto Methodist Hospital - Baytown, TX Oct 2006 to Apr 2007
Respiratory Therapist Office in Viet Nam Dec 1999 to Oct 2002
Marketing Manager of Tridem Pharma Rep Office in Viet Nam 1998 to Nov 1999
Sales Manager of Alcon Representative Office in Viet Nam 1992 to 1998
District Manager of GlaxoWellcome Representative

College of Professional Study- Northeastern University - Boston, MA Apr 2012
Master of Science in Regulatory Affair University of Texas medical Branch - Galveston, TX Aug 2008
Bachelor of Science San Jacinto College May 2006 Tourist Faculty of Ha Noi Open University 1997
Bachelor of Art in Business Administration Medical & Medicine University in Ho Chi Minh City 1992
Doctor of Dentistry in Ho Chi Minh City-Viet Nam

Knowledge of clinical trial clinical site management and monitoring, Informed Consent Document, Investigators Brochure and other trial related documents, IRBs, sponsor and investor obligations and other regulations related to human subject protection. Knowledge of various regulatory activities like dossier filing and submission , technical documents like CTDs and eCTDs Knowledge of key regulatory submissions like IND,NDA/BLA, IDE, 510(k), PMA, HDE. Knowledge of US regulations for Drugs, Biologics and Medical Devices, Overview of Japan Medical Devices regulations and submission. Knowledge of US FDAs regulations on Post-Approval requirements, Reporting, Labeling and Advertising/Promotion, off label promotion, generics and biosimilar products Ability to pay attention to details and well organize the documentation. Ability to learn and stay abreast of regulations pertinent to food, drug, biologic, and medical device Ability to assume multitask and pay attention to details Ability to function well as a member of the team and build relationship among multiple areas of an organization Computer proficiency in Microsoft Office: MS Word, Excel, and PowerPoint. Ability to manage tiny nuances of data in a multigigaby Knowledge of clinical trial clinical site management and monitoring, Informed Consent Document, Investigators Brochure and other trial related documents, IRBs, sponsor and investor obligations and other regulations related to human subject protection. Knowledge of various regulatory activities like dossier filing and submission , technical documents like CTDs and eCTDs Knowledge of key regulatory submissions like IND,NDA/BLA, IDE, 510(k), PMA, HDE. Knowledge of US regulations for Drugs, Biologics and Medical Devices, Overview of Japan Medical Devices regulations and submission. Knowledge of US FDAs regulations on Post-Approval requirements, Reporting, Labeling and Advertising/Promotion, off label promotion, generics and biosimilar products Ability to pay attention to details and well organize the documentation. Ability to learn and stay abreast of regulations pertinent to food, drug, biologic, and medical device Ability to assume multitask and pay attention to details Ability to function well as a member of the team and build relationship among multiple areas of an organization Computer proficiency in Microsoft Office: MS Word, Excel, and PowerPoint. Ability to manage tiny nuances of data in a multigigabyte documents that are thousands of page long Experience working with diverse cultures and cross functional team. Experience working with technical documentation. Experience with project management and adherence to time schedules. Excellent English in speaking, reading and demonstrated strong writing/technical writing skills

United Space Alliance at NASA/Johnson Space Center - Houston, TX Apr 2007 to Apr 2011
Engineer IV - ISS International Liaison Group United Space Alliance at NASA/Johnson Space Center - Houston, TX Jun 1998 to Apr 2007
Engineer I-IV - Mission Operations Planner

University of Houston - Houston, TX May 2011
Master of Science in Space Architecture New Mexico Institute of Mining and Technology - Socorro, NM May 1998
Bachelor of Science in Electrical Engineering

Management Skills Training Development Project Management Personnel Development Strategic Management Recognizing Conflicts of Interest Space Flight Resource Management IT Skills MS Office including Project, Access, Word, Excel, PowerPoint, and Outlook Basic Web Design using MS Frontpage, Sharepoint and HTML AutoCAD, 3D Studio Max, Adobe Photoshop, Linux/UNIX OS, LabVIEW, Matlab, PSpice, Maple, Netmeeting, Integrated Planning System (IPS), Consolidated Planning System (CPS), ISS Mission Tools Audio and Visual Design, Software and Hardware Installation, Database Development Laboratory Skills Standard Equipment: Oscilloscopes, Function Generators, Digital Multimeters, Current Transformers, Data Acquisition Systems, Signal Processing Units. Circuit Board Construction and Testing Audio and Visual Equipment Deploy