Quintiles Consulting
Industry: Company
DescriptionParent organization: Quintiles Medical Communications & Consulting, Inc. Subsidiary: Eidetics, Inc.
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Quintiles Consulting Employees
Genentech June 2015 - Present
Quintiles Consulting September 2013 - June 2015
Quintiles Transnational March 2011 - September 2013
Quintiles November 2006 - March 2011
Telluride Reservations Center August 2003 - May 2006
Skills
Competitive Analysis, Strategy, Marketing Strategy, Market Research, Management, Lead Generation, New Business Development, Biotechnology, Process Improvement, Analysis, Sales Management, Enterprise Software, Business Development, Project Management, Proposal Writing, Sales, Strategic Planning, Negotiation, Marketing, Customer Management, Account Management, Cross-functional Team..., Budgets, Team Building, CRM, Pricing
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2008 — 2010
MBA
University of North Carolina at Chapel Hill 1996 — 2000
BA, International Studies- Environmental Science concentration
Quintiles April 2015 - Present
Quintiles April 2010 - Present
Quintiles Consulting April 2009 - April 2010
EMC September 2006 - January 2009
DATATRAK International, Inc. January 2000 - May 2006
Cleveland Clinic Foundation 1995 - 1999
Memorial Sloan-Kettering Cancer Center September 1986 - May 1988
Skills
Clinical Trials, Clinical Data Management, 21 CFR Part 11, EDC, Clinical Operations, Clinical Development, GCP, Oncology, Pharmaceutical Industry, Clinical Research, Process Redesign, CRO, CTMS, Computer System..., Informatics, Regulatory Submissions, Data Management, Regulatory Affairs, Pharmaceutics, FDA, Validation, Lifesciences, Sop, Pharmacovigilance, Medical Devices, CAPA, GxP, Biotechnology, Drug Development, Life Sciences, Protocol
Education
Cleveland State University 1992 — 1995
MBA, Health Care Administration
University of Dayton 1984 — 1987
MS, Microbiology/Immunology
Westminster College (PA) 1980 — 1984
BS, Biology
GlenOak HS 1976 — 1980
PriceSpective June 2013 - Present
Quintiles Consulting March 2012 - June 2013
Quintiles Consulting October 2008 - March 2012
Deloitte Consulting LLP 2005 - 2008
Huron Consulting Group 2004 - 2005
Capgemini 2003 - 2004
Skills
Management Consulting, Pharmaceutical Industry, Strategy, CRM, Analytics, Market Access, Health Economics, Healthcare, Cross-functional Team..., Business Strategy, Data Analysis, Project Management, Market Research, Lifesciences
Education
Yale School of Public Health 2001 — 2003
Master of Public Health (M.P.H.), Health Management & Policy
Cornell University 1997 — 2001
BA, Biology
Quintiles January 2015 - Present
Quintiles Consulting February 2007 - Present
Wyeth 2001 - 2006
FDA 1973 - 2001
Skills
GMP, Biotechnology, Validation, Change Control, Regulatory Affairs, Pharmaceutics, Pharmaceutical Industry, Lifesciences, Quality System, Medical Devices, Regulatory Requirements, Quality Control, Clinical Development, Regulatory Submissions, CAPA, Commercialization, Technology Transfer, V&V, 21 CFR Part 11, CRO, Clinical Trials, Sop, FDA, Biopharmaceuticals, Computer System..., GCP, Quality Assurance, Quality Auditing, Quality Management, R&D
Education
University of North Carolina at Chapel Hill 1971 — 1973
MSPH, Public Health, Radiological Hygiene
University of North Carolina at Chapel Hill 1967 — 1971
BS, Physics
Nortech Systems June 2014 - Present
Devicix, LLC October 2008 - June 2014
Technical Compliance, LLC January 2001 - June 2014
Quality Management Partners February 2010 - January 2011
St. Jude Medical 2007 - 2007
Ferro Pfanstiehl 1999 - 2007
Quintiles Consulting February 2001 - April 2003
Day & Zimmermann Validation Services 1999 - 2001
Amgen 1992 - 1994
Skyland Scientific 1990 - 1993
Skills
FDA, Quality System, Validation, CAPA, Quality Assurance, ISO 13485, V&V, Medical Devices, Change Control, Manufacturing, Testing, Quality Management, Regulatory Affairs, Design Control, Continuous Improvement, Project Management, Program Management, ISO 14971, Cleaning Validation, Biotechnology, Technical Writing, Design of Experiments, Biomedical Engineering, Cross-functional Team...
Education
Gonzaga University - School of Business Administration 1997 — 1999
Masters, Organizational Leadership
Montana State University-Bozeman 1986 — 1990
B.S., Microbiology
Digital Realty October 2012 - Present
Quintiles Consulting March 2011 - August 2011
The Davis Companies September 2009 - May 2010
Centro Properties Group (formerly New Plan Excel Realty Trust) April 2002 - January 2009
JLT Services 2000 - 2002
Skills
Financial Reporting, Variance Analysis, Accounts Receivable, Financial Statements, Cash Flow Forecasting, Budgets, JD Edwards, Pivot Tables, Yardi, Finance, Cash Flow, Excel, Access, Microsoft Office, Training, ERP, Microsoft Excel, Financial Modeling, Analysis, Internal Controls, Month End Close, Budgeting, CAM, Journal Entries, PeopleSoft, Timberline, Accounts Payable, Procedure Development, Vlookup, Process Efficiency, Procedures Documentation, Sarbanes-Oxley, Sage FAS Fixed Assets, Yardi Voyager, Adobe Acrobat
Education
State University of New York College at Oswego
Bachelor of Science, Finance
Highland High School
Norris Technical Writing Services 2011 - Present
LFB USA April 2015 - August 2015
Synta Pharmaceuticals 2012 - 2015
Genzyme 2004 - 2011
Ilex Oncology 2002 - 2004
ILEX Oncology, Inc. 2001 - 2002
Alliance Pharmaceuticals 2000 - 2001
Quintiles Consulting 1998 - 2000
Quintiles 1995 - 1998
Quintiles 1992 - 1995
Skills
Technical Writing, Writing, Medical Writing, Oncology, Clinical Development, Clinical Trials, Biotechnology, CRO, Regulatory Submissions, Pharmaceutical Industry, CTMS, Clinical Research, Regulatory Affairs, GCP, Protocol, FDA, Drug Development, Sop, Clinical Study Design, Infectious Diseases, Biopharmaceuticals, Therapeutic Areas, Neurology, Pharmaceutics, Lifesciences, 21 CFR Part 11, Immunology, Cancer, Drug Discovery, SOP, Life Sciences
Education
The University of Texas at Austin
BA, Psychology, Spanish
Pellerite Medical Device Consulting Chairman, Medical Device Compliance CommitteeBecker & AssociatesApril 2011 - November 2012
Quintiles Consulting 2005 - 2007
U.S. Food & Drug Administration 1984 - 2005
FDA 1984 - 2005
Skills
CAPA, Complaint Handling, Investigations, Management Review, QSR, FDA, Medical Devices, Quality Systems, Surveillance, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, ISO 13485, Quality Auditing, V&V, Lifesciences, Complaint Management, Technology Transfer, Regulations, 21 CFR Part 11, Change Control, GMP, Biotechnology, Quality Control, Clinical Research, Regulatory Submissions, Regulatory Requirements, Pharmaceutics, Validation, ISO 14971, GxP, Design Control, PMA, Quality Management, Private Investigations, Sop, Clinical Trials, Strategy, Oncology, Clinical Development, R&D, GLP, ISO, Hardware Diagnostics, Biopharmaceuticals, Drug Development, Computer System..., GCP, Life Sciences
Education
Penn State 1966 — 1970
Otsuka Pharmaceutical Companies (U.S.) September 2013 - Present
ADAMAS Consulting September 2011 - August 2013
Quintiles Consulting January 2005 - March 2011
Quintiles Europe August 2003 - January 2005
Quintiles April 1999 - August 2003
Ligand Pharmaceuticals April 1996 - April 1999
SmithKline Beecham January 1993 - April 1996
SmithKline Beecham January 1989 - January 1993
SmithKline Beecham January 1985 - January 1989
Skills
GCP, Pharmaceuticals, Medical Device, Inspection readiness, Training Delivery, Pharmacovigilance, Product Liability, Management, Healthcare, Quality Control, Process Improvement, Work Process Development, Pharmaceutical Industry, Biotechnology, CRO, Clinical Development, Clinical Research, Medical Devices, Quality Assurance, SOP, FDA, Clinical Trials
Education
University of Phoenix 2014 — 2016
MHA, Health Care Administration/Informatics, 4.0
University of San Diego 2001 — 2003
Spanish Certificate, Language
College Misericordia
BSN, Nursing
Quintiles Consulting
Skills
Data Analysis, Biostatistics, Clinical Research, Managed Care, Statistics, Pharmaceutical Industry, Oncology, Healthcare, Outcomes Research, Clinical Development
Education
Columbia University Mailman School of Public Health 2008 — 2010
MS, Biostatistics
Accurate Consultants, Inc. January 1999 - Present
Quintiles Consulting 1999 - Present
Advance Tissue Sciences January 1989 - February 1999
Skills
FDA, CAPA, Regulatory Affairs, ISO 13485, Training, ISO, Internal Controls, Environmental Monitoring, Failure Analysis, SOP development, Medical Devices, Pharmaceutical Industry, 21 CFR Part 11, Quality System, Validation, Biotechnology, Sop, V&V, Change Control, GMP
Education
ASQ 1993 — 1994
CQE, Quality Engineering
University of Mississippi School of Medicine 1980 — 1982
MS, Pathology, Immunopathology
Gettysburg College 1976 — 1980
BA, Biology
Baxter Healthcare January 2009 - Present
Baxter Healthcare September 2005 - December 2008
Abbott Laboratories March 2004 - December 2004
American Technical Consultants May 2003 - March 2004
Quintiles Consulting July 2001 - May 2003
Abbott Laboratories May 2000 - July 2001
Jordan Pharmaceuticals, Inc May 1999 - December 1999
APP Pharmaceuticals March 1998 - May 1999
Skills
Task-oriented, Project-oriented, Team-oriented, Works well with people, Works well individually, Validation, GMP, GLP, Testing, Quality Assurance, GDP, Aseptic Processing, V&V, Biotechnology, Quality System, Quality Control, Microbiology, FDA, Medical Devices, 21 CFR Part 11, Change Control, CAPA, Sop, Cross-functional Team..., Pharmaceutical Industry, Sterilization, Manufacturing, ISO, Biopharmaceuticals, Environmental Monitoring, FDA GMP, ISO 13485, SOP
Education
Keller Graduate School of Management of DeVry University 2004 — 2007
Master of Business Administration (MBA), Health Services, 3.72
Keller Graduate School of Management of DeVry University 2004 — 2006
Master of Project Management, 3.72
Tuskegee University 1993 — 1997
BS, Biology
Morseth Consulting, LLC January 2004 - Present
Milestone Biomedical Associates January 2000 - January 2004
Quintiles Consulting January 1998 - January 2000
Covance Laboratories, Inc January 1993 - January 1998
FDA January 1990 - January 1993
Hazleton Laboratories America, Inc January 1984 - January 1990
Adria Laboratories, Inc January 1978 - January 1979
International Research and Development Corp January 1976 - January 1978
Skills
IND, FDA, Vaccines, CRO, Toxicology
Education
Washington State University 1980 — 1984
Ph.D, Psychology
Washington State University 1980 — 1982
M.S, Psychology
Washington State University 1979 — 1980
B.S, Psychology
Kalamazoo College 1972 — 1976
B.A, Biology
Kinapse April 2014 - Present
Quintiles Consulting September 2012 - April 2014
Adlab January 2012 - May 2012
Zipcar August 2011 - December 2011
Wellesley Information Services May 2011 - August 2011
University of Massachusetts September 2008 - May 2009
Skills
Analysis, Management Consulting, Project Management, Healthcare Industry, Business Strategy, Market Research, Pharmaceutical Industry, Organizational Design, Strategic Planning, Strategic Sourcing, Clinical Development, Risk Based Monitoring, Regulatory Operations, Business Process Design, Program Development, Program Management, Change Management, Marketing Strategy
Education
Boston Latin School
Boston University - School of Management
Business Administration, Marketing, Business Law
University of Massachusetts at Amherst - Isenberg School of Management
Bachelor of Science, Business Administration; Accounting
Harvard University August 2010 - Present
Quintiles Consulting June 2008 - Present
US Department of Health and Human Services June 2013 - May 2014
Fair Isaac Corporation April 2007 - April 2008
Authentidate Holding Corp July 2006 - April 2007
Authentidate 2006 - 2007
Dendrite International August 2003 - July 2006
Dendrite September 2000 - August 2003
Compac Sorting Equipment April 1999 - September 2000
Broadcast Communications 1998 - 1999
Skills
Health Policy, Health Decision Modeling, Healthcare Reform, Healthcare Consulting, Health Technology..., Health Economics, Healthcare, Pharmacoeconomics, Pharmaceuticals, Analytics, Pharmaceutical Industry, Decision Modeling, HTA, Health, Health Care Reform, Strategy, Management, New Business Development, Cross-functional Team..., Lifesciences, Product Development, Oncology, Product Management, Informatics, Clinical Trials, Product Launch, Segmentation, SAS, Data Analysis, Data Management, Consulting, Commercialization, Competitive Intelligence, Marketing, Medical Devices, Life Sciences
Education
Harvard University 2010 — 2016
PhD, Health Policy
University of Auckland 1993 — 1998
BE (Hons), Electronic Engineering
Boehringer Ingelheim 2013 - Present
Cook Pharmica 2011 - 2013
Amgen 2006 - 2011
Eli Lilly & Company 2004 - 2006
Hollister-Stier Laboratories 1999 - 2004
Quintiles Consulting 1997 - 1999
Osmonics/Glegg January 1993 - January 1997
US Army 1984 - 1989
Skills
GMP, FDA, Validation, Change Control, Project Management, Biotechnology, CAPA, Technology Transfer, Biopharmaceuticals, Quality System, Cross-functional Team..., Pharmaceutical Industry, Capital Project..., SOP, Engineering, Facilities Management, Team Leadership, Capital Projects, Capital Project Planning
Education
Florida Atlantic University 1989 — 1993
Bachelor of Science (BS), Mechanical Engineering
Quintiles Consulting June 2014 - Present
AGR BioPharma Consulting October 2009 - May 2014
Protean Biopharma Consulting September 2011 - April 2014
Sunovion/Sepracor Pharmaceuticals August 2007 - July 2009
GSK May 1992 - August 2007
Education
Massachusetts College of Pharmacy and Health Sciences
BS Pharmacy, Pharmacy
Pace University - Lubin School of Business
MBA, Marketing
Carlson Dash, LLC December 2011 - Present
von Briesen & Roper June 2004 - December 2011
Kenosha Area Business Alliance February 2003 - May 2004
The Upper Deck Company July 2002 - November 2002
Quintiles Consulting 2000 - April 2002
Skills
Social Media, Legal Research, Litigation Support, Litigation, Legal Discovery, Toxic Tort, Business Litigation, Product Liability, Document Review, Project Management, Management, Trials, Civil Litigation, Legal Writing
Education
Carthage College 2004 — 2004
Paralegal Certificate, Paralegal
University of Wisconsin-Parkside 1993 — 2001
B.A., Communications
PwC August 2013 - Present
PwC June 2012 - August 2012
Quintiles Consulting January 2012 - May 2012
Fidelity Investments May 2011 - August 2011
Skills
Cross-functional Team..., PowerPoint, Strategic Planning, Management, Strategy, Teaching, Mergers & Acquisitions, Data Analysis, Healthcare, Financial Analysis, Market Research, Leadership, Microsoft Excel, Financial Modeling, Analysis, Microsoft Word, Economics, Statistics
Education
Boston University Questrom School of Business 2009 — 2013
BSBA, Finance, Operations, and Information Systems, Minor in Economics
Acton-Boxborough Regional High School 2005 — 2009
High School Diploma
Fenn School
Quintiles Consulting April 2014 - Present
Skills
Program Management, Analysis, Forecasting, Clinical Trials, Oncology, CRO, Pharmaceutical Industry, Clinical Research, Biotechnology, Gastroenterology, CTMS, GCP, ICH-GCP, Cross-functional Team..., Sop, Process Improvement, Project Management, Outsourcing Management, Performance Metrics, Performance Benchmarking, Respiratory Therapy, Business Process..., Regulatory Submissions, Clinical Development, Clinical Data Management, Informatics, Drug Development
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2009 — 2011
MBA
University of Delaware 1993 — 1997
B.A.
LMT Consulting, LLC November 2008 - Present
Quintiles Consulting 2000 - October 2008
B. Braun Medical, Inc. 1998 - 2000
Food and Drug Administration 1988 - 1998
Skills
FDA, Regulatory Affairs, Sop, Quality Assurance, CRO, Medical Devices, Clinical Research, Training, Pharmaceutics, Clinical Trials, GCP, Clinical Development, Pharmaceutical Industry, CTMS, Regulatory Submissions, Auditing, Consulting, SOP development, Mock FDA Inspections, Clinical CAPAs, CQA, Fraud Detection, Regulatory Requirements, Regulatory Guidelines, CAPA, EDC, Vaccines, Biopharmaceuticals, GLP, 21 CFR Part 11, GMP, Biologics, Pharmacovigilance, Drug Development, Cross-functional Team..., Protocol, Biotechnology, Therapeutic Areas, Regulations, Neurology, Validation, Oncology, Lifesciences, Immunology, Infectious Diseases, FDA GMP, SOP, Life Sciences
Education
East Stroudsburg University of Pennsylvania 1979 — 1987
BA, Sociology/Anthropoly
Scranton Central
Kendall-Leahy LLC June 2011 - Present
Quantalytics February 2009 - Present
A Better Chance Masconomet, Inc 2005 - Present
Masconomet Regional School Committee 2004 - Present
Quintiles Consulting June 2008 - January 2009
Affinity VideoNet September 2005 - October 2007
Lightkeeper Consulting July 1998 - September 2005
Linkage Inc January 1996 - June 1998
Fox Consulting Group January 1994 - December 1995
Carnegie Mellon University Software Engineering Institute December 1992 - December 1993
Education
American University 1989 — 1990
MSHR, Organizational Development
Princeton University 1966 — 1970
A.B., Architecture & Urban Planning
Harvard University Graduate School of Education
Ed.M., Admin, Planning & Social Policy
RETIRED October 2014 - Present
KiK Krajewscy March 2014 - September 2014
SVMI Inc. October 2010 - January 2014
Boston Scientific July 2005 - February 2011
Quintiles Consulting 2005 - 2006
Cordis January 2005 - July 2005
Bionutritional Lab. March 2003 - December 2004
Horizon Medical April 2002 - December 2002
Ismeca December 2000 - April 2002
Edwards Lifesciences 1992 - 2000
Skills
FDA, Transfer, Validation, Medical Devices, ISO 13485, Sop, R&D, V&V, 21 CFR Part 11, GMP, Quality Assurance, Pharmaceutical Industry, Quality System, Manufacturing, CAPA, SPC, Product Development, Testing, Software Documentation, Process Simulation, Change Control, Design Control, IEC 60601, ISO 14971, Program Management, Design of Experiments, Quality Auditing, Quality Control, ISO, Computer System..., Regulatory Affairs, FMEA, Six Sigma, Quality Management
Education
Technical University of Lodz 1962 — 1966
BS
Quintiles Consulting 2001 - Present
Baxter Healthcare 1998 - 2001
U.S. Food and Drug Administration 1991 - 1997
Skills
FDA, Medical Devices, CAPA, Pharmaceutical Industry, Regulatory Affairs, Quality System, Quality Management, Validation, 21 CFR Part 11, Quality Control, Quality Assurance, Lifesciences, ISO 13485, GLP, Six Sigma, V&V, GxP, Testing, GMP, Sop, Change Control, Quality Auditing, Computer System..., ISO 14971, Design Control, Regulatory Requirements, SOP, Aseptic Processing, Clinical Trials, FDA GMP, Life Sciences
Education
California State University-Long Beach 1988 — 1991
BSEE, Electrical Engineering, Software, Computer and ASIC design
Meridian Life Science, Inc. October 2014 - Present
QA3 Consulting Inc. November 2008 - Present
Cardinal Health April 2011 - March 2013
Cardinal Health November 2010 - April 2011
Quintiles Consulting 2006 - 2008
Roche Diagnostics 2005 - 2006
Jacobs Engineering 2002 - 2004
Pharmaceutical, Medical Device & Biotechnology Firms 1998 - 2002
Bayer 1994 - 1998
Zeagen/Coors Biotech 1987 - 1991
Skills
CAPA, Change Control, FDA, Validation, ISO 13485, ISO 14971, GAMP, Quality System, GMP, Medical Devices, V&V, Quality Assurance, Quality Control, Biotechnology, Sop, Aseptic Processing, R&D, Pharmaceutics, Laboratory, Technology Transfer, Regulatory Requirements, Pharmaceutical Industry, Regulatory Affairs, Manufacturing, Lifesciences, Clinical Trials, Quality Auditing, Clinical Research, 21 CFR Part 11, GxP, Testing, Process Improvement, Microbiology, Sterilization, Clinical Development, Computer System..., Technical Writing, Biopharmaceuticals, GLP, Quality Management, Oncology, SOP, Life Sciences
Education
University of Kentucky
MS
Quintiles Consulting April 2008 - Present
Defined Health July 2005 - October 2007
Monitor Group May 2003 - July 2005
Bogart Delafield Ferrier October 1998 - May 2003
Education
Rutgers, The State University of New Jersey-Newark 1988 — 1991
MBA
Brown University 1981 — 1985
Sc.B., Biochemistry
ProPharma Group June 2014 - Present
Eliassen Group for Genzyme Corporation May 2013 - June 2014
Eliassen Group for Shire HGT July 2012 - January 2013
Quintiles Consulting December 2011 - April 2012
Apotex Inc. July 2011 - December 2011
Vectech Pharmaceutical Consultants March 2011 - May 2011
SQA Services June 2010 - October 2010
Accucaps Industries Ltd. June 2007 - September 2008
Catalent Pharma Solutions September 2004 - November 2006
Purdue Pharma October 2003 - May 2004
Skills
Validation, FDA, CAPA, SOP, Technology Transfer, Change Control, Analytical Chemistry, Cleaning Validation, cGMP, Process Validation, Quality Assurance, LIMS, GLP, Auditing, Compliance, R&D, Chemistry, Manufacturing, Quality Auditing, Process Improvement, Process Development, Chromatography, Organic Chemistry, GMP Investigations, Stability, Sop, V&V, GMP, Quality System, ISO, ISO 13485, Pharmaceutical Industry, Aseptic Processing, 21 CFR Part 11, GxP, Quality Management, Purification, Regulatory Affairs, Gas Chromatography, Biopharmaceuticals, Root Cause Analysis, Computer System..., Regulatory Submissions, Biotechnology, Pharmaceutics, Laboratory, Formulation, UV, Regulatory Requirements, Lifesciences
Education
Bloomfield College 1990 — 1994
B.S, Chemistry
JHS 17
None January 2010 - Present
Cordis Corporation 2005 - 2007
Quintiles Consulting November 2005 - December 2006
Guidant Corp 1988 - 2004
ACS/GUIDANT 1988 - 2004
Advanced Cardiovascular Systems 1989 - 1995
Skills
Design Control, R&D, Process Simulation, FDA, CAPA, Medical Devices, V&V, ISO 13485, Validation, Quality System, 21 CFR Part 11, GMP, Regulatory Affairs
Education
Coventry University 1962 — 1967
1965
Quintiles Advisory Services March 2015 - Present
Quintiles Consulting April 2013 - Present
Foundation for Global Skin Health Strategies April 2009 - Present
Quintiles Consulting May 2012 - April 2013
RTI Health Solutions June 2010 - May 2012
Philips Healthcare October 2009 - May 2010
GeNO, LLC March 2009 - May 2010
New York State Institute for Basic Research July 2008 - July 2009
Precision Biosciences January 2009 - May 2009
New York State Institute for Basic Research July 2001 - July 2008
Skills
Biotechnology, Pharmaceutical Industry, Lifesciences, Market Research, Oncology, Business Strategy, Strategy, Clinical Trials, Clinical Development, Medical Devices, Clinical Research, Health Economics, Business Development, Biochemistry, Market Access, Personalized Medicine, Commercialization, Market Analysis, Drug Development, Outcomes Research, Medical Diagnostics, Molecular Diagnostics, Cell Therapy, HTA, Management Consulting, Start-ups, Biomedical Engineering, Pharmacology, Healthcare Reimbursement, Point of Care, Medical Imaging, Stem Cell Technology, Integration, R&D, Regenerative Medicine, Health Technology..., Healthcare Consulting, Life Sciences Consulting, Entrepreneurship, Gene Therapy
Education
Duke University - The Fuqua School of Business 2008 — 2010
M.B.A., Health Sector Management, and Corporate Finance
State University of New York at Stony Brook 1990 — 2001
B.S., Ph.D., Chemistry, Molecular and Cellular Pharmacology
Halloran Consulting Group, Inc. May 2015 - Present
Halloran Consulting Group, Inc. November 2014 - May 2015
Quintiles Consulting November 2013 - November 2014
Avarent Consulting LLC March 2013 - November 2014
Baxter Healthcare November 2007 - March 2013
Boston Scientific 2004 - 2007
Control Delivery Systems 2001 - 2004
Skills
Medical Devices, Pharmaceutical Industry, FDA, Clinical Development, Clinical Trials, Validation, Regulatory Affairs, CAPA, Cross-functional Team..., GCP, Biotechnology, Clinical Research, Product Launch, Regulatory Submissions, Pharmacovigilance, Lifesciences, Medical Device Marketing, Voice of the Customer, Key Opinion Leaders, Product Requirements, V&V
Education
Lake Forest Graduate School of Management 2011 — 2013
Master of Business Administration (MBA), Organizational Behavior Studies, Graduated with High Honors
Thomas Jefferson University
Master of Science (M.S.), Medical Microbiology and Bacteriology
Mount Holyoke College
Biology/Biological Sciences, General
HHS/ASPR/BARDA August 2015 - Present
Tunnell Consulting, Inc. March 2014 - Present
University of Phoenix April 2005 - Present
KP MEX,LLC October 2011 - March 2014
Quintiles Consulting 2012 - 2012
Novavax October 2005 - September 2011
Bowie State University 2006 - 2009
Alpharma 2003 - 2005
Baxter 1990 - 2003
North American Vaccine 1990 - 2001
Skills
Sop, Validation, Quality System, FDA, GMP, Quality Control, Change Control, Medical Devices, GLP, ISO 13485, GCP, Technology Transfer, Auditing, Product Development, Internal Audit, Quality Assurance, Pharmaceutical Industry, Biotechnology, Vaccines, Quality Auditing, Regulatory Affairs, Manufacturing, Laboratory, Program Management, Clinical Research, Training, Management, Biopharmaceuticals, 21 CFR Part 11, Lifesciences, V&V, CAPA, Aseptic Processing, Leadership
Education
Capella University 2003 — 2005
Doctor of Philosophy (Ph.D.), Organizational Leadership and Human Resources Management, GPA 4.0
University of Maryland University College 1998 — 2002
MBA, Business
North Carolina Central University 1972 — 1976
BS, Biology
Quintiles Consulting 2012 - Present
Market Strategies 2008 - 2011
Harris Interactive 2004 - 2008
AstraZeneca 2003 - 2004
AstraZeneca 1997 - 2003
Skills
Market Intelligence, Competitive Intelligence, Segmentation, Market Analysis, Marketing Research, Market Research, Analytics, Primary Research, Quantitative Research, Competitive Analysis, Customer Insight, Focus Groups, Pharmaceutical Industry, Consumer Behaviour, Data Analysis, Positioning, Survey Design
Education
Cornell University 1993 — 1997
Bachelor of Science, Business Administration and Marketing
GC America January 2009 - July 2012
TAUT Inc. July 2006 - August 2008
Quintiles Consulting November 1998 - June 2006
Personal Proucts Inc, Johnson and Johnson November 1996 - October 1998
The Dial Corporation 1987 - 1997
Skills
Quality System..., Corrective &..., Risk Assessment, Project Management, Quality Engineering, Document and Change..., Process Validation -..., Quality System Audits;..., CAPA, Medical Devices, FDA, Change Control, V&V
Education
Knox College 1982 — 1987
Bachelor of Arts (BA), Chemistry
Knox College 1982 — 1986
Bachelor of Arts (BA), Biology
TotalCareRx 2014 - Present
Manhattan Research 2013 - 2013
Quintiles Consulting 2011 - 2012
Self-employed 2009 - 2011
Catalent (formerly Cardinal Health) 2005 - 2009
Datamonitor 2000 - 2002
Pfizer 1995 - 1998
Pfizer Pharmaceuticals 1991 - 1995
Skills
Business Development, Drug Development, Management, Pharmaceutical Industry, Market Research, Strategic Partnerships, Cross-functional Team..., Pharmaceutics
Education
City University of New York, Queens College
BFA, Fine Art, Education
Pace University - Lubin School of Business
Marketing
Stuyvesant High School
RRD International, LLC July 2006 - December 2014
Intarcia Therapeutics January 2000 - July 2006
Quintiles Consulting September 1997 - December 1999
FDA June 1987 - September 1997
Education
University of Maryland - Robert H. Smith School of Business 1993 — 1995
MBA
University of Colorado School of Medicine 1973 — 1977
MD
Grinnell College 1969 — 1973
BA, Biology
Underwriters Laboratories February 2010 - Present
Underwriters Laboratories July 2001 - February 2010
Quintiles Consulting 1999 - 2001
Oak Grove Technologies Inc. 1998 - 1999
Morton Grove Pharmaceuticals 1996 - 1998
Skills
UL, Engineering, Root Cause Analysis, Product Safety, Quality System, Validation, Testing, FDA
Education
University of Southern California 1993 — 1996
BS, Chemical Engineering
Lake Forest Academy 1990 — 1993
NIAID/NIH [C], Office of Regulatory Affairs 2003 - Present
NIH 2003 - Present
GJP Quality Services March 1998 - Present
Quintiles 1999 - 2005
Quintiles Consulting 1999 - 2005
Axys Pharmaceuticals 1998 - 1999
MAST Immunosystems May 1997 - February 1998
Bachem California January 1994 - September 1996
Bachem 1994 - 1996
Peninsula Laboratories May 1993 - December 1993
Education
University of Minnesota Duluth 1972 — 1973
None, Analytical Chemistry
Northwestern University 1968 — 1972
Ph.D., Physical Organic Chemistry
St. Norbert College 1962 — 1967
B.S., cum Laude, Chemistry, Mathematics, Philosophy
New York Blood Center 2011 - Present
American Red Cross Biomedical Headquarters 2008 - June 2011
American Red Cross January 2004 - June 2011
American Red Cross January 2004 - June 2011
2004Abbott Laboratories March 1999 - January 2004
Abbott Labs March 1999 - 2004
Abbott Laboratories 1999 - 2004
Quintiles Consulting January 1998 - January 2000
Kirkegaard & Perry Laboratories January 1996 - January 1998
The Bionetics Corporation January 1994 - January 1996
Skills
Quality Assurance, FDA, Operations Management, GMP, Validation, Quality System, Regulatory Affairs, Biotechnology, CAPA, Medical Devices, Technology Transfer, Pharmaceutical Industry, Vaccines, Quality Control, Sop, SOP, Cross-functional Team..., Process Improvement
Education
University of Maryland University College 1999 — 2001
M.S., Biotechnology
C.W. Post/Long Island University
M.S. Program; M.S, Quantitative Systems & Analysis; achieved; Biotechnology Management
State University of New York College at Plattsburgh 1975 — 1979
BS, Biochemistry/Biophysics/Chemistry
Quintiles Consulting February 2009 - Present
Northwestern University October 2004 - May 2005
Education
Northwestern University 2004 — 2008
BA, Mathematics
Gwen Ryan Solutions, LLC February 2004 - Present
Ade Therapeutics September 2009 - Present
Nostrum Laboratories, Inc. 2011 - 2013
Quintiles Consulting 2007 - 2008
Nostrum Pharmaceuticals 2004 - 2006
Kos Pharmaceuticals 2002 - 2004
Schering-Plough Pharmaceuticals June 2000 - August 2002
Mylan Technologies September 1993 - February 2000
Wyeth Pharmaceuticals January 1990 - September 1993
Skills
Drug Development, CRO, Formulation, Pharmaceutics, Strategy, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, GMP, Clinical Development, FDA, Project Management, Validation, Sop, Lifesciences, Regulatory Submissions, Technology Transfer, Chemistry, R&D, Biopharmaceuticals, Quality System, 21 CFR Part 11, CMC, Regulatory Requirements, Team Leadership, GLP, ANDA, Clinical Trials, GCP, CAPA, V&V, SOP, Change Control, Quality Auditing, Cross-functional Team..., Quality Assurance, Management, Medical Devices
Education
University of Vermont College of Medicine 1994 — 1999
PhD, Pharmacology
University of Vermont College of Medicine 1990 — 1992
M.S., Biochemistry
Providence College 1977 — 1981
Bachelor's Degree, Biology
Life Technologies August 2009 - February 2012
CV Partners / XenoPort October 2008 - July 2009
Atos Origin August 2007 - July 2008
Scientific Careers January 2007 - July 2008
Quality Compliance Partners June 2007 - September 2007
Averent July 2006 - September 2006
Genentech August 2004 - July 2006
IT&E Consulting May 2004 - August 2004
Quintiles Consulting June 2002 - April 2004
Atrix Laboratories February 2001 - October 2001
Skills
Validation, 21 CFR Part 11, CAPA, Change Control, Computer System..., Cross-functional Team..., FDA, Medical Devices, Process Improvement, Quality Assurance, Quality Control, Quality System, Software Documentation, Sop, Testing, Quality Management, ISO, Biotechnology, Life Sciences, Pharmaceutical Industry, GMP, Management, Quality Auditing
Education
Metro State College 1984 — 1988
BA, Athletic Training (Sports Medicine)
Fort Lewis College 1982 — 1983
Business Management
Aims Community College 1982 — 1982
Chemical Testing Technology
Leica Microsystems July 2015 - Present
Transilwrap Company, Inc. July 2013 - June 2015
Atlas Software Technologies, Inc. August 2012 - April 2013
Premier Luxury Suites, Inc August 2011 - July 2012
Levine Companies January 2005 - August 2011
Quintiles Consulting January 2003 - January 2005
Levine Companies January 1998 - January 2003
Wesley Jessen 1991 - 1993
Wesley Jessen 1991 - 1993
Wesley Jessen 1991 - 1993
Skills
Budgets, Management, Project Management, Process Improvement, Negotiation, Software Documentation, Human Resources, Finance, Contract Management, Business Development, Marketing, Insurance, Business Process..., Account Management, Project Coordination, Proposal Writing, MS Project, Business Process..., Invoicing, Leadership, Bid Preparation, Pricing, Employee Training, Customer Service, Team Building, Sales
Education
University of Phoenix 2010 — 2012
Master of Business Administration (M.B.A.), Global Management, 3.9/4.0
State University of New York 1986 — 1989
Bachelor of Arts, French & Political Science
Quintiles November 2014 - Present
Quintiles Consulting July 2013 - November 2014
Novartis June 2012 - June 2013
Duke University Medical Center January 2009 - July 2011
Duke University Medical Center June 2007 - December 2007
Center for Disease Control 2006 - 2006
Skills
Outcomes Research, Pharmacoeconomics, Oncology, Market Access, Biostatistics, Epidemiology, Clinical Research, Public Health, Health Economics, Clinical Study Design, Medical Writing, Clinical Operations, Clinical Development, Pharmaceutical Industry, Cancer
Education
Columbia University Mailman School of Public Health 2011 — 2012
MPH, Effectiveness and Outcomes Research
Georgia Institute of Technology 2004 — 2008
BS, Chemistry
Novartis Vaccines and Diagnostics May 2013 - Present
Novartis Vaccines December 2012 - May 2013
Quintiles Consulting November 2011 - November 2012
Lilly del Caribe Guayama March 2005 - November 2011
Lilly del Caribe Mayagüez October 2003 - March 2005
Abbott Laboratories Barceloneta, June 2001 - October 2003
Skills
GMP, Compliance, CAPA, Start-ups, Quality Assurance, Process Validation, Complaints Management, Event Management, Change Management, C&Q, Quality Systems, Root Cause Analysis, Self Assessment, V&V, Quality System, Sop, FDA, Pharmaceutical Industry, Validation, Change Control, Quality Management, Cleaning Validation, Manufacturing, Deviations, Aseptic Processing, Complaint Management, SOP, GxP
Education
University of Puerto Rico 1996 — 2001
Bachelor, Chemical Engineering