Falcon Consulting Group, LLC
Industry: Company
DescriptionFounded: 2010 Parent organization: Avaap USA, LLC
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Falcon Consulting Group, LLC Employees
Morphotek, Inc. March 2011 - 2014
Falcon Consulting Group, LLC 2007 - 2010
Center for Sleep Medicine 2005 - 2007
United Biosource 2004 - 2005
Penn Medicine (University of Pennsylvania Health System) 2001 - 2004
Skills
Clinical Trials, Pharmaceutical Industry, Oncology, Clinical Development, Lifesciences, 21 CFR Part 11, FDA, GCP, Validation, Clinical Research, CRO, Data Management, Sop, Biopharmaceuticals, Multiple Sclerosis, Treatment of depression
Education
Goucher College 1996 — 1997
Masters of Arts in Teaching Program; 21 credits, 3.8 GPA
Towson University
Bachelor of Science (BS), Psychology, 3.4 GPA
Society of Quality Assurance 2014 - Present
PPD January 2012 - Present
Falcon Consulting Group, LLC January 2011 - January 2012
Falcon Consulting Group, LLC September 2007 - January 2011
Society of Quality Assurance January 2007 - December 2007
PPD May 2006 - September 2007
Endo Pharmaceuticals December 2000 - March 2006
Hoffmann-La Roche 1998 - 2000
Otsuka America Pharmaceuticals, Inc. 1991 - 1998
Skills
International Auditing, GXP expertise, Compliance Training, GxP, GCP, Pharmaceutical Industry, FDA, 21 CFR Part 11, CRO, CTMS, Sop, Regulatory Affairs, Clinical Development, Regulatory Submissions, Clinical Monitoring, Clinical Trials, Clinical Research, Quality Assurance, GLP, Drug Development, SOP, Validation
Education
Frostburg State University 1972 — 1975
BA, General Science
Richard Montgomery High School 1970 — 1972
Ursuline Academy 1968 — 1970
Saint Mary's 1960 — 1968
PRA Health Sciences September 2014 - Present
RPS Poland, Sp. z.o.o. January 2013 - September 2013
GCP Consulting June 2012 - January 2013
Cephalon Inc., October 2008 - June 2012
Falcon Consulting Group, LLC July 2004 - October 2008
Covance CLS June 1999 - July 2004
Astra Pharmaceuticals, AstraMerck, AstraZeneca September 1997 - June 1999
Skills
GCP, Clinical Trials, Auditing, Quality Assurance, Compliance, GxP, CRO, Quality Auditing, Clinical Development, ICH-GCP, Clinical Monitoring, Clinical Data Management, Drug Development, CTMS, 21 CFR Part 11, Computer System..., Sop, Pharmaceutical Industry, Software Documentation, FDA, Validation, Regulatory Affairs, Quality Management, Regulatory Submissions
Education
Московский Государственный Университет им. М.В. Ломоносова (МГУ)
MS, Economics, Materials Science
OBrien CQA, LLC January 2013 - Present
LifeSci Compliance, LLC July 2012 - December 2012
Falcon Consulting Group, LLC January 2011 - June 2012
Falcon Consulting Group LLC April 2009 - January 2011
Falcon Consulting Group, LLC September 2007 - April 2009
Cato Research May 2007 - August 2007
Cato Research August 2003 - May 2007
Cato Research February 1998 - August 2003
Skills
GCP, Clinical Trials, CRO, 21 CFR Part 11, Pharmaceutical Industry, Sop, Clinical Research, Clinical Development, FDA, CTMS, Validation, Oncology, Biotechnology, IND, Medical Writing, EDC, CAPA, Quality Assurance, Quality Control, Biopharmaceuticals, Quality Auditing, SOP
Education
North Carolina State University 1994 — 1998
PhD, Immunology
North Carolina State University 1991 — 1994
Master of Science (M.S.), Biological Engineering
Mississippi State University 1985 — 1989
BS, Biological Engineering
Falcon Consulting Group, LLC July 2009 - Present
WQATS, LLC May 2000 - July 2011
MedFocus, LLC (corp-to-corp) October 2008 - January 2009
AtheroGenics, Inc. May 2000 - September 2008
Education
Chadwick University 1997 — 2003
M.S., Psychology
Claflin University 1974 — 1978
B.S., Chemistry
Claflin University 1974 — 1978
Claflin University 1974 — 1978
bs, chemistry
Shire Pharmaceuticals 2014 - Present
Shire Pharmaceuticals 2006 - 2014
Falcon Consulting Group, LLC 2004 - 2006
Adolor 2000 - 2004
Omnicare Inc. 1999 - 2000
IBAH / BioPharm Clinical Services 1994 - 1999
Skills
Pharmaceutical Industry, Clinical Trials, GCP, Regulatory Affairs, GxP, FDA, CRO, Regulatory Submissions, Sop, CAPA, 21 CFR Part 11, Computer System..., Validation, Biotechnology, Clinical Research, Quality Assurance, Clinical Development, Quality System, Oncology, Drug Development, MHRA, R&D, CTMS, GLP, IND, Biopharmaceuticals, Pharmacovigilance, Change Control, Regulatory Requirements, ICH-GCP, EDC, Vaccines, V&V, Technology Transfer, Due Diligence, Medical Affairs, SOP
Education
Temple University 1995 — 2000
M.S., Pharmacy - RA/QA
Bloomsburg University of Pennsylvania 1987 — 1991
B.S.
LaSalle College High School 1983 — 1987
Comcast Business July 2014 - Present
Falcon Consulting Group, LLC September 2013 - July 2014
Falcon Consulting Group, LLC December 2012 - July 2014
First Judicial District of Pennsylvania September 2007 - November 2007
European Commission May 2007 - August 2007
Falcon Consulting Group, LLC May 2005 - July 2005
Skills
International Law, Legal Research, Nonprofits, International Trade, Policy Analysis, Project Coordination, Restaurant Management, Bartending, Martial Arts Instruction, Contract Management, Recruiting, Proposal Writing, Subcontracts Management
Education
Temple University - James E. Beasley School of Law 2005 — 2008
Juris Doctor, Law (International Law, Corporations)
Belmont University 2002 — 2005
BA, Theatre and Drama
Illumina, Inc May 2014 - October 2014
Dendreon Corporation May 2013 - April 2014
Writing Assistance, Inc 2009 - 2014
Your Encore, Inc. February 2005 - 2014
Merz Pharmaceuticals, LLC January 2011 - May 2012
Falcon Consulting Group, LLC August 2008 - May 2009
i3 Statprobe January 2005 - June 2008
Allergan, LLC July 2003 - December 2003
La Jolla Pharmaceutical Company July 2001 - January 2003
NAMSA January 1999 - August 2000
Skills
Medical Writing, Clinical Development, Regulatory Submissions, Medical Affairs, Pharmacology, Pharmaceutical Industry, Oncology, GCP, Clinical Research, Pharmaceuticals, Medical Devices, Journal Manuscripts,..., Grant Applications,..., University Teaching, Medical Education, Preclinical Research, Established..., Protocol, Immunology, Clinical Trials, Neurology, SOP, CRO, Biopharmaceuticals, Vaccines, Dermatology, Biotechnology, Therapeutic Areas
Education
University of California, Santa Barbara
NIH postdoctoral research fellowship (NRSA National Institute on Aging)
University of Oregon; University of California Santa Barbara
PhD
University of California, Santa Barbara
Masters Degree
ACCQ Writing Services, Inc. April 2009 - Present
MannKind Corporation2008-2009 December 2008 - April 2009
Falcon Consulting Group, LLC 2007 - 2008
ACCQ Writing Services, Inc. 2000 - 2007
Skills
Microsoft Office, Word, Excel, SAS, SharePoint, Adobe Acrobat, VBA, Visual Basic, MS Office Automation, Medical Writing, Technical Documentation, Visual Studio, Web Design, Web Development
Education
Lake City Community College
Associates, Science and Engineering program
Ocean County College
Associates, Applied Science Program
Falcon Consulting Group, LLC February 2015 - Present
ICON plc May 2013 - January 2015
Bristol-Myers Squibb January 2011 - May 2013
Falcon Consulting Group October 2004 - January 2011
Skills
Pharmaceutical Industry, Clinical Trials, GCP, 21 CFR Part 11, CRO, Clinical Development, Sop, CTMS, Oncology, EDC, Clinical Monitoring, Lifesciences, Drug Development, Life Sciences, SOP, Quality Assurance, Clinical Research
Education
Temple University
Masters, Quality Assurance Regulatory Affaires
Quintiles August 2015 - Present
Quintiles May 2015 - Present
Sarah Cannon Research Institute April 2014 - April 2015
PPD August 2011 - April 2014
Falcon Consulting Group, LLC February 2011 - June 2011
Schulman Associates IRB, Inc. December 2009 - February 2011
Community Research October 2007 - February 2009
INC Research August 2000 - August 2007
Skills
GCP, CRO, Clinical Trials, EDC, CTMS, Pharmaceutical Industry, FDA, Clinical Monitoring, Clinical Research, Sop, Clinical Development, 21 CFR Part 11, ICH-GCP, Clinical Data Management, Oncology, Regulatory Affairs, Regulatory Submissions, Biotechnology, Pharmacovigilance, Validation, Project Management, Quality Assurance, Consulting, Information Technology, IRB, SMO, Global Central..., Compliance Oversight, 21 CFR, Training Management, Lifesciences, Computer System..., Protocol, Vaccines, Diabetes, Regulatory Requirements, Hematology, Data Management, FDA GMP, Laboratory Automation, Global Operations, Database Design, Life Sciences, SOP
Education
Indiana University East
Business Administration, Management and Operations
Indiana University-Purdue University at Indianapolis
Falcon Consulting Group, LLC August 2012 - August 2013
Worldwide Clinical Trials, Inc. April 2012 - August 2012
Adolor 2007 - 2011
Falcon Consulting Group, LLC 2004 - 2007
Adolor 2000 - 2004
INGENIX PHARMACEUTICAL SERVICES (formerly Worldwide Clinical Trials) 1998 - 2000
Skills
Clinical Research, CRO, Clinical Monitoring, Clinical Development, Clinical Trials
Education
Bloomsburg University of Pennsylvania
Bachelor of Science
Edinboro University of Pennsylvania
Bachelor of Science