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Derwood, MD, 20855
... preparation Medical Information Collaboration with Marketing Initiatives CMC documents including stability reports and assay validation Authored FDA briefing documents for meetings PROFESSIONAL EXPERIENCE Consultant/Contractor BioPharm Global, Inc. ...
- 2017 May 31
Fairfax, VA, 22030
... Assistance Committee projects, US Congress 2007, 2008, 2009, 2010, 2012 Interpreter for Food and Drug Administration (FDA) inspection in Indonesia, August 2009 Simultaneous interpreter for Rule of Law program for Indonesian law enforcement ...
- 2017 May 24
Reston, VA
... It involves integration with Salesforce, 3rd party legacy systems, SAP, FDA, master data hubs etc. Integrating systems Salesforce, Lionbridge (Language Translation), FDA Electronic Submission gateway, SAP, Product and Customer data hubs Solution ...
- 2017 May 17
Fairfax, VA
... 2003 Food and Drug Administration (FDA) ● Subject Matter Expert for analysis of software systems development process at an Agency level. ● Designed agency-wide System Development Life-Cycle (SDLC) compliant with OMB 300 requirements and in ...
- 2017 May 15
Washington, DC
... Food & Drug Administration White Oak, MD Records Management Subject Matter Expert Supported the development and establishment of a clear and unified direction for FDA Records Management Program• Address targeted needs for electronically stored ...
- 2017 May 04
Potomac, MD
... OTHER POSITIONS HELD at SRA Lead Enterprise Architect / Technical Lead for NIH May 2004 – Oct 2005 Senior NIH Requirement Analyst Jan 2004 –May 2004 SRA FDA Data Warehouse Architect Sept 2002 – Dec 2004 SRA CDC Project/Test Engineer Jan 2000 – Aug ...
- 2017 May 01
Herndon, VA, 20170
... Environment: Windows XP/Windows 2003, UNIX,ALM, Oracle, Quality Center, J2EE, XML, Web Services, JavaScript, HTML, XML, PVCS, Oracle, MS Project and MS Office FDA, Rockville, MD Jan’06 - Sep’07 Role: QA Analyst Project: Devices Registration and ...
- 2017 Apr 27
Washington, DC, 20002
... Supported the study research coordinator to submit new trials and protocol amendments to FDA and IRBs. Coordinated to the exportation of investigational products. Novo Nordisk S/A (Danish Pharmaceutical Company) São Paulo, Brazil Senior Regulatory ...
- 2017 Apr 19
Fairfax, VA
... Work with relevant personnel to evaluate new security technologies Food and Drug Administration (FDA) Responsible for analyzing security requirements and designing the security architecture for the Electronic Submissions Gateway (E-Submissions) ...
- 2017 Apr 02
Herndon, VA, 20170
... SENIOR SOFTWARE ENGINEER (PROJECT MANAGER) Lent technical leadership to the Adverse Event Reactions System (AERS), developed projects for the Food and Drug Administration (FDA), and implemented Capability Maturity Model (CMM) level II standards for ...
- 2017 Mar 24