McCormick LifeScience Consultants, LLC

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McCormick LifeScience Consultants, LLC Employees

Employee
Years
Job
Industry
Frank Faunce Frank Faunce Greater Chicago Area Details
Frank Faunce's McCormick LifeScience Consultants, LLC Experience 2007 - 2007
Job Regulatory Operations Experience
Industry Pharmaceuticals
Experience
AbbVie  September 2010 - Present
Millennium Pharmaceuticals, Inc.   September 2007 - September 2010
Medfocus  July 2007 - September 2007
Mercom Group   September 2005 - July 2007
McCormick LifeScience Consultants, LLC   2007 - 2007
Bristol-Myers Squibb Medical Imaging  September 2004 - September 2005
Wyeth  August 2000 - September 2004

Skills
IDMP, eCTD, 21 CFR Part 11, Regulatory Submissions, Document Management, Regulatory Affairs, Pharmaceutical Industry, SharePoint, Sop, Software Documentation, Computer System..., Validation, Cross-functional Team..., FDA, GxP, GCP, GMP, Clinical Trials, IND, Clinical Development, InSight Manager, Insight Publisher, InSight Viewer, eCTDXPress, ISIPublisher, GlobalSubmit, Publishing, Citrix, Documentum, FirstDoc, Planisware, PowerPoint, Adobe Acrobat, Outlook, Visio, Microsoft Excel, Microsoft Word, Excel, Word, FDA ESG

Education
Boston University   2001 — 2005
BS

New York University   1997 — 1998

Allen Fleishman, PhD PStat Allen Fleishman, PhD PStat Greater Boston Area Details
Allen Fleishman, PhD PStat's McCormick LifeScience Consultants, LLC Experience October 2011 - Present
Job President at Allen Fleishman Biostatistics
Industry Pharmaceuticals
Experience
McCormick LifeScience Consultants, LLC   October 2011 - Present
Allen Fleishman Biostatistics   September 2000 - Present
Barrington James Pharmaceutical recuitment   2015 - 2015
Boston Biostatistics (Averion)   October 1998 - September 2000
CIBA Vision  March 1995 - March 1996
Johnson & Johnson Pharmaceutical Research Institute   March 1993 - March 1995
Johnson & Johnson Ethicon  February 1992 - 1993
Sandoz  1989 - January 1992
Lederle Laboratories  1980 - 1989
PAREXEL  June 1966 - October 1968

Skills
Biostatistics, Statistical Programming, Statistical Consulting, Data Analysis, SAP, Protocol Design, ISS, Power Analysis, ISE, Statistical Analysis..., Team Management, Clinical Trials, CRO, Analysis, FDA, Diabetes, Therapeutic Areas, Biotechnology, Clinical Development, Life Sciences

Education
University of Illinois at Urbana-Champaign   1972 — 1978
PhD

City University of New York   1971 — 1972
BS

Stephen Mullen Stephen Mullen Greater Boston Area Details
Stephen Mullen's McCormick LifeScience Consultants, LLC Experience June 2011 - June 2015
Job Manager, Quality Assurance at TEI Biosciences Inc.
Industry Medical Devices
Experience
TEI Biosciences Inc.  March 2013 - Present
Middlesex Community College  May 1995 - Present
Middlesex Community College  2000 - Present
McCormick LifeScience Consultants, LLC   June 2011 - June 2015
AdvanSource Biomaterials Corp.   September 2007 - April 2011
Biogen Idec  September 2005 - September 2007
Bristol-Myers Squibb  September 2002 - September 2005
Bristol-Myers Squibb  March 1999 - September 2002
DuPont Pharmaceuticals  January 1992 - September 2002
DuPont Merck  September 1996 - September 1998

Skills
Sop, GMP, Quality Assurance, Quality System, Biotechnology, Root Cause Analysis, FDA, Trackwise, Quality Control, Change Control, Technology Transfer, Validation, GxP, 21 CFR Part 11, Manufacturing, LIMS, Pharmaceutical Industry, Clinical Development, HPLC, CAPA, Lifesciences, GLP, Regulatory Affairs, Analytical Chemistry, Biopharmaceuticals, Laboratory, Clinical Trials, ISO 13485, Regulatory Submissions, Microbiology, V&V, Chemistry, Medical Devices, Chromatography, Regulatory Requirements, ELISA, Pharmaceutics, Purification, Quality Auditing, R&D, SOP development, Drug Development, Design Control, CRO, FDA GMP, Cell Culture, Vaccines, Gas Chromatography, Computer System..., Protocol

Education
Springfield College   1989 — 1992
BS

Middlesex Community College   1989 — 1991

Jacob Cooper Jacob Cooper Greater Boston Area Details
Jacob Cooper's McCormick LifeScience Consultants, LLC Experience July 2013 - Present
Job Quality Systems and Regulatory Operations Consultant at McCormick LifeScience Consultants, LLC
Industry Pharmaceuticals
Experience
McCormick LifeScience Consultants, LLC   July 2013 - Present
Handel and Haydn Society  2011 - Present
Self  1992 - Present
Lantheus Medical Imaging  July 2010 - March 2013
Alnara Pharmaceuticals   April 2009 - March 2010
Altus Pharmaceuticals  September 2007 - March 2009
Alkermes, Inc  September 2005 - August 2007
The Putney School  September 2001 - June 2004

Skills
FDA, Music, Singing, Sight Reading, Ensemble, eCTD, Proofreading, Editing, SOP authoring, Document Management, Change Control, Classical, Validation, Oratorio, Microsoft Office, Choral, GMP, Opera, Quality System, Vocalist, Sop, SOP, Bass, Software Documentation

Education
Longy School of Music   1999 — 2001
Early Music Voice Performance

University of Denver   1992 — 1997
Music

Heather Valley, RAC Heather Valley, RAC Greater Boston Area Details
Heather Valley, RAC's McCormick LifeScience Consultants, LLC Experience 2009 - April 2010
Job Prin RA Specialist Medtronic
Industry Medical Devices
Experience
Medtronic  April 2015 - Present
Atrium Medical/Maquet Getinge Group  September 2013 - April 2015
Philips Healthcare  April 2011 - September 2013
Pleiad Inc  March 2010 - December 2010
McCormick LifeScience Consultants, LLC   2009 - April 2010
Shire HGT  August 2009 - March 2010
Vertex Pharmaceuticals  February 2008 - December 2008
Rapid Micro Biosystems  2003 - 2007
Millipore  2001 - 2003

Skills
FDA, Regulatory Affairs, Biotechnology, Lifesciences, Medical Devices, Regulatory Submissions, Pharmaceutical Industry, GMP, GLP, Clinical Trials, CAPA, Validation, ISO 13485, Microbiology, Biopharmaceuticals, Quality Assurance, Quality System, 21 CFR Part 11, Clinical Development, R&D, V&V, Design Control, Change Control

Education
University of Massachusetts Lowell   2005 — 2008
Masters Degree, Clinical Laboratory Sciences

University of Massachusetts Lowell   2003 — 2005
Clinical Pathology Certificate, Pathology

University of Massachusetts, Amherst   1996 — 2001
Bachelors Degree, Microbiology

Claire Walsh (Polleys) Claire Walsh (Polleys) Greater Boston Area Details
Claire Walsh (Polleys)'s McCormick LifeScience Consultants, LLC Experience November 2014 - Present
Job Senior Regulatory Consultant at McCormick LifeScience Consultants
Industry Pharmaceuticals
Experience
McCormick LifeScience Consultants, LLC   November 2014 - Present
Braintree Laboratories  November 2012 - November 2014
Braintree Laboratories  August 2005 - November 2012
Braintree Laboratories  February 2000 - August 2005
Chiron Diagnostics/Bayer Diagnostics   1995 - 2000

Skills
Regulatory Submissions, Regulatory Affairs, Clinical Research, Medical Writing, Regulatory Requirements, Quality Assurance, Clinical Data Management, Clinical Monitoring, IND, GxP, Medical Affairs, Computer System..., Pharmacovigilance, Clinical Operations, ICH-GCP, Drug Development, Change Control, GCP, GLP, GMP, Clinical Trials, Sop, Communication, 21 CFR Part 11, Pharmaceutical Industry, FDA, CAPA, SOP

Education
Regis College   2003 — 2005
MS, Health Product Regulation/Health Policy

Boston University   2001 — 2003
Public Health

Regis College   1991 — 1995
Master's degree, Biology, Chemistry, English

RAPS
RAC, RAC

Debra B. Feldman Debra B. Feldman Greater Boston Area Details
Debra B. Feldman's McCormick LifeScience Consultants, LLC Experience September 2012 - July 2014
Job Senior Director Regulatory Affairs at Medivector Inc
Industry Biotechnology
Experience
Medivector Inc  March 2015 - Present
DB Feldman Consulting   April 2008 - Present
McCormick LifeScience Consultants, LLC   September 2012 - July 2014
Pfizer Pharmaceuticals (Formerly FoldRx Pharmaceuticals)   May 2010 - July 2012
Artisan Pharma   June 2008 - December 2009
AMAG Pharmaceuticals  January 2006 - April 2008
EPIX Pharmaceuticals  2000 - 2006

Skills
Pharmaceutical Industry, Clinical Development, Regulatory Affairs, Clinical Trials, FDA, Biotechnology, Clinical Research, Lifesciences, Drug Development, CMC Regulatory Affairs, GCP, IND, Regulations, Regulatory Submissions, Biologics, Biopharmaceuticals, GMP, CRO, CTMS, Sop, Oncology, Regulatory Requirements, GxP, Vaccines, Therapeutic Areas, eCTD, Pharmacology, GLP, Technology Transfer, NDA, Change Control, Drug Discovery, 21 CFR Part 11, Validation, Drug Safety, Medical Affairs, Medical Writing, Protocol, Aseptic Processing, EDC, Infectious Diseases, V&V, Pharmaceutics, CAPA, ICH-GCP, Clinical Monitoring

Education
Boston University   1999 — 2003
MPH, Masters in Public Health

University of Massachusetts, Amherst
Bachelors

Radha Iyengar Radha Iyengar Greater Boston Area Details
Radha Iyengar's McCormick LifeScience Consultants, LLC Experience June 2009 - Present
Job Executive Director, Intellectual Property at Mersana Therapeutics
Industry Biotechnology
Experience
Mersana Therapeutics  October 2012 - Present
McCormick LifeScience Consultants, LLC   June 2009 - Present
IP Consulting  May 2009 - Present
Mersana Therapeutics  August 2010 - September 2012
Magen BioSciences   January 2007 - April 2009
NitroMed Inc.  1998 - 2006
SunOpta  1988 - 1998
Institute for Enzyme Research, Madison, WI   1982 - 1985
Fox Chase Cancer Center  1980 - 1982

Education
Brown University   1975 — 1979
Ph.D, Chemistry

Indian Institute of Technology, Kanpur   1973 — 1975
M.Sc., Chemistry

Loreto House, Kolkatta

Alisia Collett Alisia Collett Greater Boston Area Details
Alisia Collett's McCormick LifeScience Consultants, LLC Experience January 2012 - Present
Job Sr. Nonclinical Writer at McCormick LifeScience Consultants, LLC
Industry Biotechnology
Experience
McCormick LifeScience Consultants, LLC   January 2012 - Present
Stryker Biotech  June 2008 - October 2011
ViviSource Labs   July 2006 - June 2008
Azopax Therapeutics   October 2005 - June 2006
Phylogix, Inc.   August 2004 - September 2005

Skills
ELISA, In Vivo, Non-clinical, Pharmacology, Pre-clinical Studies, Scientific Writing, Editing, Biotechnology, Regulatory Submissions, Regulatory Documentation, DMPK, Animal Work, Laboratory, Data Analysis, CRO, Animal Husbandry, In Vitro, Toxicology, Surgery, Microbiology, Drug Delivery

Education
Franklin Pierce College   1996 — 2000
BA, Anthropology

Roger E. Wells, DVM, MS, DACVP Roger E. Wells, DVM, MS, DACVP Greater Boston Area Details
Roger E. Wells, DVM, MS, DACVP's McCormick LifeScience Consultants, LLC Experience April 2009 - Present
Job Toxicologic Pathologist at Consulting Tox/Path, LLC
Industry Biotechnology
Experience
McCormick LifeScience Consultants, LLC   April 2009 - Present
Consulting Tox/Path Services, LLC   June 1983 - Present
University of New Hampshire  January 1983 - Present
McCormick LifeScience Consultants, LLC   May 2009 - October 2009

Skills
Life Sciences, Pathology, Research, Diagnostics, Teaching

Education
Michigan State University   1978 — 1981
Masters in Pathology, Veterinary Pathology

The Ohio State University   1968 — 1972
Doctor of Veterinary Medicine, Veterinary Medicine

Anderson College   1965 — 1968
Preveterinary Medicine