Datafarm, Inc
Industry: Company
DescriptionFounded: 1997
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Datafarm, Inc Employees
Digital Infuzion August 2014 - Present
Digital Infuzion March 2013 - Present
Digital Infuzion May 2012 - August 2012
Amnesty International July 2011 - November 2011
Women's Institute for Freedom of the Press May 2011 - July 2011
Datafarm Inc October 2009 - May 2010
YMCA Camp Nellie Huckins July 2007 - August 2008
Skills
Writing Skills, Product Marketing, Communication, Marketing Communications, Text Editing, Copy Editing, Web Design, Human Rights Education, Social Media Marketing, International Human..., Critical Thinking, Graphic Design, Time Management, Marketing, Public Speaking
Education
Elon University 2009 — 2013
Bachelor of Arts (B.A.), English Literature, Peace and Conflict Studies, Women and Gender Studies, Graduated Cum Laude
University of the Witwatersrand 2011 — 2011
Human Rights
Lincoln Sudbury Regional High School 2005 — 2009
Med Immune May 2011 - Present
Fannie Mae November 2007 - January 2011
Computer Sciences Corporation January 2007 - November 2007
Pfizer January 2006 - December 2006
Intel Corporation May 2005 - January 2006
Datafarm Inc October 2004 - April 2005
Xerox Global Services June 2004 - September 2004
Wright State University March 2001 - December 2003
Servion Global Solutions June 2000 - December 2000
Skills
Documentum, Records Management, J2EE, Content Management, Business Analysis, XML, SharePoint, Java Enterprise Edition, SDLC, Validation, Document Management, FDA
Education
Wright State University 2001 — 2003
MS, Computer & Electrical Engineering
University of Madras 1996 — 2000
BE, Computer Science
Regulatory eSubmissions, LLC April 2010 - Present
Radius Health, Inc. March 2015 - August 2015
Teva Pharmaceuticals September 2011 - July 2013
Datafarm Inc January 2009 - March 2010
Merck & Co., Inc. October 1996 - October 2008
Merck February 1989 - January 1995
Skills
eCTD, Regulatory Submissions, Document Management, Business Analysis, Lifesciences, FDA, Pharmaceutical Industry, 21 CFR Part 11, IND, Process Improvement, Regulatory Requirements, Vendor Management, Strategy, Computer System..., Pharmaceutics, Software Documentation, Regulations, Regulatory Affairs, Business Process, Sop, SDLC
Education
New Jersey Institute of Technology 1980 — 1982
MS, Computer & Information Science
Ramapo College of New Jersey 1974 — 1978
BS, Chemistry, Computer Science
Datafarm Inc January 2000 - March 2010
Skills
Business Analysis, Change Management, Regulatory Requirements, Biotechnology, Microsoft Office
Education
Yale University - Yale School of Management 1984 — 1986
MBA, Finance
Duke University 1977 — 1981
BA, Economics
Almac Group February 2013 - Present
Floating Fish Studios II January 1990 - Present
Datafarm Inc 2008 - 2010
Floating Fish Studios 1990 - 2009
Octagon Research Solutions 2002 - 2007
University of Pennsylvania Health System Division of Community Radiology January 1999 - December 2001
Donnelly Directory 1989 - 1991
Skills
Leadership, Management, Networking, SharePoint, Advertising, Editing, Databases, Regulatory Submissions, SQL, Quality Assurance, FDA, Regulatory Affairs, Troubleshooting, Testing, Pharmaceutical Industry, Training
Education
Shippensburg University of Pennsylvania 1984 — 1988
B.A., Communications, Radio/TV/Film, Speech Minor
Dyax February 2013 - Present
Dyax January 2012 - February 2013
Dyax December 2010 - December 2011
Liquent June 2010 - December 2010
Datafarm Inc March 2007 - June 2010
Christian Performing Artists' Fellowship June 2001 - August 2004
MasterWorks Festival 2001 - 2004
Skills
eCTD, Regulatory Submissions, FDA, Biotechnology, Document Management, Pharmaceutical Industry, Sop, Regulatory Affairs, IND, Regulatory Requirements, Computer System..., Lifesciences, GCP, CRO, Clinical Trials, Clinical Data Management, Clinical Development, SOP, Life Sciences
Education
Boston University 2005 — 2008
Master of Music, Trombone Performance
Towson University 1996 — 2001
Bachelor of Arts, Music Education - Instrumental
Advanced eCTD Submissions
Preparing Compliant eCTD Submissions
Texas Tech University 2004 — 2005
Music Performance
Sunovion Pharmaceuticals Inc. November 2008 - Present
MGI Pharma (Eisai) June 2007 - November 2008
Bristol-Myers Squibb Medical Imaging July 2006 - June 2007
Datafarm, Inc November 2005 - June 2006
Genzyme contracting through Randstad August 2003 - September 2005
Genzyme December 2001 - August 2003
Genzyme contracting through Randstad January 2001 - December 2001
Skills
Medical Imaging, Medical Writing, Clinical Development, Central Nervous System, Clinical Trials, Regulatory Affairs, Oncology, Pharmaceutical Industry, FDA, Regulatory Submissions, Biostatistics, Clinical Research, GCP, Sop, Biotechnology, Drug Development, IND, CRO, 21 CFR Part 11, Protocol, Clinical Study Design, Lifesciences, Regulatory Requirements, Cardiology, ICH-GCP, Therapeutic Areas, Drug Safety, eCTD, Biopharmaceuticals, EDC, Pharmacovigilance, Clinical Monitoring, Drug Discovery
Education
University of Massachusetts, Amherst 2003 — 2006
BS, Neuroscience concentration in psychology
UnitedHealth Group October 2014 - Present
LiVi Learning Solutions, Inc. December 2012 - December 2014
LiVi Learning Solutions, Inc. April 2010 - December 2014
Datafarm Inc June 2008 - February 2010
Medidata Solutions August 2007 - May 2008
Medidata Solutions January 2006 - July 2007
Savatree June 2005 - January 2006
MedAllies January 2002 - June 2005
Skills
Adobe Captivate, Articulate Studio, Microsoft Office, SnagIt, PowerPoint, Filezilla, Adobe Connect, Adobe Presenter, Adobe Acrobat, Soundbooth, ePath Learning, Visio, E-Learning, Instructional Design, Project Management, LCMS, Firefox, Curriculum Design, Curriculum Development, Instructional Technology, Training, Captivate, Learning Management...
Education
Walden University 2010 — 2010
Certificate, Instructional Design and Technology
Jones International University 2003 — 2005
M. Ed., Corporate Training & Knowledge Mgmt
State University of New York College at Buffalo 1995 — 2001
B.S., computer information systems
Cephalon Inc. March 2009 - August 2010
Datafarm Inc August 2007 - January 2008
Sanofi Pasteur June 2007 - August 2007
ALZA Corporation October 2005 - November 2005
Liquent February 2003 - June 2003
Liquent April 2002 - February 2003
Liquent April 2000 - 2001
Liquent June 1995 - April 2000
Siemens March 1990 - June 1995
Skills
eCTD, FDA, Documentum, Regulatory Affairs, 21 CFR Part 11, Document Management, Validation, Pharmaceutical Industry, Livelink, Computer System..., Testing, Software Documentation, Change Control, Regulatory Requirements, Quality Assurance, GxP, Sop
Education
Pennsylvania State University-Great Valley Graduate Center 1990 — 1992
M.E, Computer Engineering
Indian Institute of Telecommunication Engineers 1984 — 1989
Isis Pharmaceuticals January 2013 - Present
Isis Pharmaceuticals April 2010 - January 2013
Datafarm Inc November 2007 - April 2010
PAREXEL Consulting 2000 - 2008
PAREXEL International January 2003 - November 2007
Vical January 2000 - January 2003
Skills
Regulatory Affairs, GCP, Clinical Trials, FDA, Sop, Drug Development, IND, eCTD, Protocol, Clinical Research, Clinical Study Design, NDA, Regulatory Submissions, Pharmaceutical Industry, IRB, Biotechnology
Education
Albion College 1995 — 1999
Independent July 2013 - Present
AVEO Pharmaceuticals August 2011 - June 2013
Verinume April 2010 - August 2011
Image Solutions Inc June 2008 - April 2010
Vertex Pharmaceuticals May 2006 - June 2008
Datafarm Inc May 2004 - May 2006
Case Consulting June 2001 - April 2004
Lucent Technologies April 1997 - June 2001
Ascend Communications 1998 - 1999
Cascade Communications February 1996 - May 1998
Skills
Validation, 21 CFR Part 11, Computer System..., FDA, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, Lifesciences, Clinical Trials, Documentum, Regulatory Requirements, Sop, eCTD, Quality System, Quality Assurance
Education
Alabama Agricultural and Mechanical University 1992 — 1994
Masters, Computer Science
Osmania University 1989 — 1991
Botany
Osmania University 1987 — 1989
ImmunoGen, Inc. July 2014 - Present
ImmunoGen, Inc. October 2010 - June 2014
Liquent June 2010 - September 2010
Datafarm Inc January 2007 - June 2010
FICO September 2005 - December 2006
RulesPower May 2004 - September 2005
Skills
Management, System Administration, NetApp, Quality Assurance, Software Documentation, SDLC, Testing, Infrastructure, SharePoint, VMware
Education
University of Hartford 2000 — 2004
PAREXEL January 2013 - Present
Liquent June 2010 - Present
Datafarm Inc. September 2009 - June 2010
Datafarm Inc September 2008 - September 2009
Merck January 2006 - September 2008
Merck July 1997 - January 2006
Skills
LAN-WAN, SAN, Windows Server, ASP.NET, IIS, Web Development, Web Project Management, Network Infrastructure, IT Infrastructure..., Solution Architecture, Microsoft SQL Server, C#, MPLS, VoIP, Microsoft Exchange, eCTD, Pharmaceutical Industry, Regulatory Submissions, Project Management, Network Design, IPSec, Budget Process, Network Security, Business Process..., Virtualization, Hyper-V, Quest vWorkspace, DNS, Disaster Recovery, Business Continuity, DHCP, System Center Suite, Team Management, Problem Solving, Private Cloud, Hybrid Cloud, Entrepreneurship, Software Development, SharePoint, Product Management, Product Development, Network Infrastructure..., Datacenter..., Server Consolidation, Storage Consolidation, Vendor Management, Telecommunications, Business Analysis, Six Sigma, Databases
Education
Drexel University
BS, Information System
Conventus Biomedical Solutions, Inc. November 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) April 2012 - November 2013
Advanced BioHealing August 2009 - April 2012
Ceregene, Inc. July 2008 - November 2008
Biogen 2007 - 2008
Datafarm Inc 2005 - 2007
Isis Pharmaceuticals 1999 - 2003
Alliance Pharmaceuticals 1998 - 1999
University of California, Santa Barbara 1997 - 1998
University of Rochester Medical Center 1995 - 1997
Skills
FDA, eCTD, Biologics, Combination Products, IMPD, EMEA, CTD
Education
Weizmann Institute of Science 1988 — 1995
Ph.D., Chemistry (Materials and Interfaces)
Princeton University 1985 — 1987
MA, Chemistry
Oberlin College 1982 — 1985
BA, Chemistry
Pharmaceutical eConsulting June 2013 - Present
Aris Global June 2012 - April 2013
Liquent January 2011 - June 2012
Liquent June 2010 - December 2010
Datafarm Inc September 2009 - May 2010
Bristol-Myers Squibb June 1999 - August 2009
Skills
eCTD, Document Management, Validation, Regulatory Submissions, 21 CFR Part 11, Business Process, Product Life Cycle..., Testing, Regulatory Operations, Regulatory Requirements, Information Management, Product Lifecycle..., FDA, SDLC, Product Management, Business Analysis, Quality System, Regulatory Affairs, Computer System..., Pharmaceutical Industry, Documentum, Change Control, Quality Assurance, Sop, Software Documentation, Clinical Trials, Clinical Data Management, Data Management, Pharmacovigilance, GCP, SOP
Education
Bryant University 1980 — 1983
BS in BA, Computer Information Systems
Datafarm Inc January 2000 - Present
datafarm 2000 - 2009
Education
Duke University
BA, Economics
Yale University - Yale School of Management
MPPM, Finance/management
Aetna December 2011 - Present
Datafarm Inc 2006 - 2010
Cleanwise, Inc. 2003 - 2006
Spryance 2000 - 2003
Equis Financial Group 1998 - 2000
TJX 1997 - 1998
Leverone Assoc 1995 - 1997
Skills
Auditing, Business Analysis, Business Process, Competitive Analysis, Financial Analysis
Education
Brandeis International Business School 1999 — 2001
MSF, International Finance
Merrimack College 1985 — 1989
BS, Accounting and Business/Management
University of Miami 1983 — 1984
Bachelor of Science, Marine Science Biology
PAREXEL 2012 - Present
Liquent 2010 - 2012
Datafarm Inc 2010 - 2012
Apyx, Inc 2005 - 2009
Otsuka Pharmaceutical Companies (U.S.) 2003 - 2005
AstraZeneca 1999 - 2003
Skills
Regulatory Affairs, Performance Management, Mergers & Acquisitions, Cross-functional Team..., Project Management, Contract Negotiation, Contract Management, Manage Client..., Regulatory Submissions, Regulatory Filings, Guidances
Education
Penn State University 1995 — 1999
Bachelor's Degree, Labor and Industrial Relations
EMC November 2013 - Present
ImmunoGen, Inc. July 2011 - July 2013
Datafarm Inc July 2009 - July 2010
Skills
Graphic Design, Vector Illustration, Logo Design, Help Desk Support, Computer Graphics
Education
Framingham State College 2004 — 2011
Bachelor of Science (BS), Design and Visual Communications, General