DR. LOI PHI NGUYEN, MD
Osteopathic Medicine at Bellaire Blvd, Houston, TX

Lead Field Technical Engineer at GE Oil & Gas

Oil & Energy

GE Oil & Gas since Oct 2011 - Lead Field Technical Engineer GE Oil & Gas Sep 2010 - Oct 2011 - Lead Test Engineer GE Oil & Gas Apr 2008 - Sep 2010 - Lead Software Engineer Hydril Sep 2005 - Apr 2008 - Software Engineer -- Control System

Texas A&M University 2004 - 2005
Master, Computer Science UTPB 2001 - 2003
BS, Computer Science & Mathematic Midland College 2000 - 2002
Ho Chi Minh City University of Technology 1991 - 1993

English, Vietnamese

Kindred Rehabilitation Hospital at Clear Lake
Registered Respiratory Therapist Triumph Hospital at Clear lake - Webster, TX
Registered RegRespiratory Therapist University of Texas Medical Branch's John Sealy Hospital - Galveston, TX
Respiratory Therapist San Jacinto Methodist Hospital - Baytown, TX
Respiratory Therapist Office in Viet Nam
Marketing Manager of Tridem Pharma Rep Office in Viet Nam
Sales Manager of Alcon Representative Office in Viet Nam
District Manager of GlaxoWellcome Representative

College of Professional Study- Northeastern University - Boston, MA
Master of Science in Regulatory Affair University of Texas medical Branch - Galveston, TX
Bachelor of Science San Jacinto College Tourist Faculty of Ha Noi Open University
Bachelor of Art in Business Administration Medical & Medicine University in Ho Chi Minh City
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

Respiratory Therapist at RehabCare Group Inc.,

Hospital & Health Care

RehabCare Group Inc., since Mar 2009 - Respiratory Therapist UTMB Apr 2006 - Aug 2008 - Respiratory Therapist-RRT

Northeastern University 2010 - 2012
MSc, Regulatory Affairs for Drugs,Biologics,and Medical Devices UTMB 2006 - 2008

Internist

8989 Westheimer Rd, Houston, TX 77063
12112 Bellaire Blvd, Houston, TX 77072

American Board of Internal Medicine Certification in Internal Medicine

CEO at Import Export Associates, Inc, President at Import Export Associates, Inc

Import and Export

Import Export Associates, Inc since Apr 2006 - CEO Import Export Associates, Inc since Apr 1996 - President

Internal Medicine, Cardiovascular Disease

Southwest Heart Ctr
8989 Westheimer Rd, Houston, TX 77063 Bellaire Cardiovascular Care PA
12112 Bellaire Blvd, Houston, TX 77072

University of Florida (1986)

Computer Hardware