PAREXEL International
Industry: Pharmaceutical company
DescriptionPAREXEL International is a global provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. Headquarters: Waltham, Massachusetts, United States CEO: Jamie Macdonald (15 Mar 2018–) Number of employees: 19,000 Founder: Josef H. von Rickenbach Founded: 1982 Subsidiaries: ClinPhone Inc, ClinPhone Ltd,
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PAREXEL International Employees
Quintiles/ Q2 Lab Solutions April 2014 - Present
USDM August 2013 - January 2014
Liaison Technologies March 2010 - August 2013
BioPharm Systems, Inc. September 2006 - March 2010
Synteract Inc. March 2006 - September 2006
Ligand Pharmaceuticals July 2003 - March 2006
Parexel International April 2002 - July 2003
Chromagen September 1999 - April 2002
Alliance Pharmaceuticals Limited June 1997 - September 1999
Alliance Pharmaceuticals Limited October 1995 - June 1997
Skills
Medidata, SDTM, Therapeutic Areas, Program Management, Integration, Management, Computer System..., Document Management, Sop, Cloud Computing, Informatics, eCRF, Healthcare, Analysis, Cross-functional Team..., Organization, Software Documentation, CTMS, Quality Assurance, Leadership, CRO, Training, Data Warehousing, Business Analysis, Oncology, Workflow, Enterprise Software, Data Analysis, Data Integration, SDLC, Merck, Full Cycle Organization, Workflow Design, CDISC, Software Implementation, Business Process, CRM, Biotechnology, Databases, Testing, Outsourcing, Pharmaceutical Industry, Clinical Trials, Data Management, Clinical Data Management, EDC, GCP
Education
Calfornia State San Marcos- High Tech Management 2001 — 2006
B.S.
San Diego Mesa College 1996 — 2001
AS
University of California, San Diego 1998 — 1999
Professional Training
Regeneron Pharmaceuticals, Inc. August 2015 - Present
PAREXEL International January 2014 - August 2015
BioReference Laboratories March 2012 - November 2013
Coughlan Products LLC March 2010 - March 2012
ClinAudits, LLC June 2009 - March 2010
Lars + Associates, Inc. September 2005 - August 2009
Skills
Business Writing, Marketing Communications, HTML/XML, Copywriting, Press Releases, Newsletters, Project Management, Public Relations, Event Planning, Publicity, Marketing, Direct Marketing, Social Media Marketing, Public Speaking, Web Content
Education
Rutgers University-New Brunswick 2014 — 2015
Ongoing - Masters Program, Clinical Trial Science - Regulatory Affairs
Rowan University
B.A., Communications/PR
Perceptive Informatics (a PAREXEL ® company) November 2013 - Present
Perceptive Informatics (a PAREXEL ® company) September 2011 - November 2013
PAREXEL International February 2010 - September 2011
Thomas D November 2008 - September 2011
UPS Store August 2006 - September 2008
Skills
Management, Access, Oracle Applications, Customer Service, Microsoft Excel, Oracle, Oracle E-Business Suite, Accounts Receivable, Outlook, Microsoft Office, PowerPoint, Microsoft Word, Windows 7, Administrative..., Process Improvement, Invoicing, Visio, Software Documentation, SharePoint, Business Analysis, Project Management, Clinical Trials, Cross-functional Team..., Pharmaceutical Industry
Education
Mount Washington College 2007 — 2009
Associate of Science Degree, Paralegal
Optaros November 2006 - Present
Citizens Bank January 2004 - November 2006
FrontSite 1997 - November 2006
IBI Group 2003 - 2004
Viant 1999 - 2001
Parexel International 1996 - 1997
CompUSA 1996 - 1997
Skills
Cloud Computing, Virtualization, Security, IT Strategy, Linux, System Administration, Integration, Troubleshooting, Windows, Agile Methodologies, Requirements Analysis, Mac, Vendor Relations, Apache, Information Technology, Agile Project Management, Project Planning, SaaS, IT Management, Cost Reduction..., Architecture, Telecommunications, Software Documentation, Open Source, Scrum, Software Project..., SharePoint, MySQL, MS Project, Disaster Recovery, Network Security, Web Applications, Amazon Web Services..., SOA, Enterprise Software, Databases, SQL, Hosting, Documentation, IT Operations, Mobile Communications, VoIP, Wireless Networking, Atlassian JIRA, Confluence, Vendor Relationships, HipChat, Salesforce.com, Fisheye, SDLC
Education
Northeastern University
Management Information Systems
AWS Solutions Architect Training 2014 — 2014
PAREXEL International June 2012 - Present
Friendlys Ice Cream Corporation June 2006 - June 2012
Friendlys Ice Cream Corporation May 2006 - June 2012
Salem State College 2007 - 2012
Salem State College September 2011 - December 2011
Skills
Research, PowerPoint, Microsoft Office, Microsoft Word, Microsoft Excel, Gel Electrophoresis, Editing, Data Entry
Education
Salem State College 2007 — 2012
Bacheor of Science, Biology, General
Clinipace Worldwide September 2014 - Present
Clinipace Worldwide May 2010 - August 2014
Paragon Biomedical (Now Clinipace Worldwide) November 2006 - May 2010
Paragon Biomedical (Now Clinipace Worldwide) May 2004 - November 2006
PAREXEL International 2002 - 2004
Skills
CTMS, Clinical Development, Clinical Monitoring, Therapeutic Areas, Clinical Data Management, CRO, ICH-GCP, Clinical Trials, GCP, Oncology, EDC, Sop, FDA, Drug Development, Clinical Research, Vaccines, Biotechnology, Infectious Diseases, Pharmaceutical Industry, Protocol, Data Management, Phase I, Regulatory Submissions, Regulatory Affairs, Clinical Operations, 21 CFR Part 11, Medical Writing, Neurology, Pharmacovigilance
Education
Purdue University 1999 — 2001
Bachelor of Science (B.S.), Health Sciences
Indiana University Bloomington 1997 — 1999
ICON Clinical Research August 2011 - Present
ICON Clinical Research August 2010 - August 2011
PAREXEL International January 2009 - August 2010
PAREXEL International August 2007 - January 2009
PPD December 2006 - August 2007
PPD December 2005 - December 2006
PPD July 2005 - December 2005
WJBD Veterans Hospital; Dorn Research Institute August 2001 - July 2005
Skills
Microsoft Office: Word,..., Electronic Data..., Other databases:..., Clinical Trials, Clinical Research, Microsoft Excel, Inform, EDC, CRO, ICH-GCP, Clinical Operations, Infectious Diseases, Protocol, Therapeutic Areas, Clinical Monitoring, Clinical Development, CTMS, Neurology, Sop, Vaccines, Diabetes, Cardiology, Patient Recruitment, Dermatology, GCP, Asthma, Clinical Data Management, Medical Devices, Hypertension, SOP, Type 2 Diabetes
Education
Midlands Technical College 1996 — 1998
Nursing, Nursing Education
PAREXEL International March 2010 - Present
Skills
CTMS, Clinical Monitoring, GCP
Education
Durham Technical Community College 2006 — 2009
AAS, Clinical Trials Research Associate
North Carolina Wesleyan College 1993 — 1995
BS, Business Administration
Novartis Vaccines & Diagnostics (through PRA Health Sciences) May 2014 - Present
PAREXEL International March 2012 - May 2014
Dana-Farber Cancer Institute October 2009 - March 2012
Cambridge Health Alliance May 2004 - January 2008
Dana-Farber Cancer Institute April 2006 - May 2006
Skills
Clinical Trials, Regulatory Affairs, Clinical Research, Regulatory Submissions, GCP, CTMS, IRB, FDA, Pharmaceutical Industry, Clinical Development, Regulatory Requirements, ICH-GCP, Sop, GLP, Protocol
Education
Northeastern University 2009 — 2010
MS, Regulatory Affairs (Domestic & International)
University of Massachusetts Boston
BS, Biology
Faculdade Italo Brasileira
BA, Foreign Trade
PAREXEL International August 2012 - Present
Self-employed CRA September 1990 - September 2007
Beta-Blocker Evaluation of Survival Trial (BEST) - VA/NIH Coop Study June 1995 - September 1999
Boots Pharmaceuticals, Inc. August 1988 - August 1990
DuPont Critical Care (DuPont Pharmaceuticals) January 1988 - August 1988
American Critical Care/American Hospital Supply Corporation April 1985 - December 1987
Skills
Clinical Research, Clinical Trials, Oncology, Neurology, GLP
Education
Southern Illinois University, Carbondale
Bachelor of Arts (B.A.), Biological Sciences
PNC Bank March 2013 - Present
Ameriprise Financial Services, Inc. February 2011 - December 2012
Gordon Consulting Services, LLC January 2002 - March 2011
ReServe Inc. 2008 - 2010
New York City Department of Health and Mental Hygiene 2008 - 2010
Jonathan Wood & Associates 2008 - 2009
Parexel International 2004 - 2007
Healthways Communications 2002 - 2003
RxCentric 2002 - 2003
Rogers Medical Intelligence Solutions 2002 - 2003
Education
University of Southern California - Marshall School of Business 1967 — 1971
MBA, Finance/Marketing (with honors)
Penn State University 1963 — 1967
BA, Industrial Relations
Liberty Central High School 1959 — 1963
Academic studies
Shire July 2015 - Present
Genzyme March 2011 - March 2015
Shire Pharmaceuticals January 2011 - March 2011
Pharmalucence 2008 - July 2010
Aerotek Professional Services 2008 - 2008
Sepracor 2003 - 2008
PAREXEL International 1999 - 2003
Skills
FDA, SharePoint, Oracle Clinical, CAPA, eCTD, Quality System, Document Management, ISO, Regulatory Affairs, Sop, Pharmaceutical Industry, Regulatory Submissions, GMP, Medical Devices, Biotechnology, GCP, Validation, GxP, Clinical Trials, CTMS, SOP, 21 CFR Part 11, Oncology, Clinical Development, Quality Assurance
Education
Middlesex Community College 2002 — 2008
AS, Liberal Science/Nursing
PAREXEL International May 2015 - Present
PAREXEL International February 2013 - May 2015
PAREXEL International November 2011 - February 2013
PAREXEL International April 2010 - November 2011
PAREXEL International June 2007 - April 2010
PAREXEL, International June 2006 - June 2007
PAREXEL, International November 2004 - June 2006
PAREXEL, International December 1999 - November 2004
PAREXEL, International January 1999 - December 1999
Duke Cancer Prevention, Detection and Control Center January 1996 - January 1999
Skills
Leadership, Management, Data Management, Databases, Research, Proposal Writing, Clinical Trials, Pharmaceutical Industry, Oncology, CRO, Clinical Research, Biotechnology, Clinical Development
Education
St. Edward's University 1989 — 1991
MBA, Finance
The University of Texas at Austin 1981 — 1985
Bachelor of Arts (B.A.), Sociology
AmerisourceBergen September 2013 - Present
AmerisourceBergen August 2010 - Present
AmerisourceBergen August 2010 - Present
Theracom, CVS Caremark Co January 2004 - Present
AmerisourceBergen April 2011 - September 2013
Parexel International May 2005 - July 2010
PAREXEL 2005 - 2010
Dominion Dental, Inc May 2000 - May 2005
StarPower, LLC October 1998 - May 2000
Skills
Medicare, Access, Healthcare, Inventory Management, Training, Medicaid, Management
Education
Strayer University 2010 — 2011
Bachelor's Degree, Criminal Justice
Strayer University 2010 — 2011
Bachelors, Criminal Justice
Strayer University 2010 — 2011
Bachelor Degree, Criminal Justice; Psychology, Sociology
Norfolk State University 1994 — 1998
Associate Degree; Interrogations, Criminal Justice 2007; Criminal Procedures; Criminal Justice, Business Law
Everest University
Areas of, Criminal Justice; Forensic Science
Lydon Communications December 2011 - Present
GaltNeedleTech February 2014 - September 2015
Aptiv Solutions March 2011 - December 2011
Facet Solutions August 2008 - January 2010
NDO Surgical, Inc. January 2008 - March 2008
NDO Surgical, Inc. March 2005 - January 2008
PAREXEL International January 2003 - February 2005
PAREXEL International January 2001 - January 2003
PAREXEL International December 1997 - December 2000
Skills
Corporate Communications, Public Relations, Integrated Marketing, Marketing, Social Media, Strategic Communications, Pharmaceutical Industry, Management, Marketing Communications, Project Management, Internal Communications, Marketing Strategy, Biotechnology, Leadership, Clinical Research, Creative Direction, Medical Devices, Cross-functional Team..., Entrepreneurship, Marketing Management, Writing, Training, Program Management, Publishing, Copy Editing, Email Marketing, Newsletters, Online Marketing, Trade Shows, Media Relations, Budgets, Market Planning, Brand Development, Photography, Resume Writing, Copywriting, Messaging, Corporate Branding, Social Media Marketing, Competitive Analysis, Press Releases, Salesforce.com, Constant Contact, Content Writing, Nonprofits, Proofreading, National Association of..., Content Development, Content Management, Strategic Partnerships
Education
Providence College 1989 — 1992
B.A., English
Wheaton College 1988 — 1989
Liberal Arts
PAREXEL International February 2015 - Present
GCP Quality Solutions, Inc. 2011 - Present
Pharma Compliance Partners, LLC 2010 - Present
Takeda Pharmaceuticals 2001 - 2010
PAREXEL 1998 - 2001
PAREXEL 1996 - 1998
Skills
Quality Assurance, GCP, Training, Clinical Research, Drug Development, Sop, Quality Auditing, 21 CFR, Pharmaceutical Industry, Regulatory Requirements, Public Speaking, Clinical Monitoring, 21 CFR Part 11, Biotechnology, Clinical Development, CAPA, Cross-functional Team..., GLP, EDC, FDA, GxP, CTMS, LIMS, Clinical Trials, CRO, GMP, Data Management, Process Simulation, Clinical Research..., Computer System..., Medical Devices, IND, Regulatory Submissions, Medical Writing, Oncology, Pharmacovigilance, V&V, Clinical Data Management, Biopharmaceuticals, Protocol, Lifesciences, Pharmaceutics, Therapeutic Areas, Infectious Diseases, ICH-GCP, SOP development, SOP
Education
Northeastern Illinois University 1989 — 1994
Bachelor of Arts, Biology
New Trier East
King's Bowl America February 2014 - Present
NOVELL, Inc January 2004 - Present
Novell July 2004 - June 2012
PAREXEL INTERNATIONAL January 2002 - January 2004
CMGI January 2000 - January 2002
BRUNSWICK BOWLING LANES January 1989 - January 2000
Addison Wesley Longman January 1998 - January 1999
ADDISON WESLEY LONGMAN January 1996 - January 1999
Addison Wesley Longman January 1996 - January 1998
PAPA GINO’S January 1990 - January 1996
Skills
Management, Customer Service
Education
Middlesex Community College 1990 — 1993
Associates Degree, Liberal Studies
Billerica Memorial High School 1986 — 1990
Graduate
inVentiv Health Clinical October 2014 - Present
Premier Research July 2014 - Present
Premier Research October 2012 - Present
PAREXEL International March 2010 - September 2012
PPD, Inc. August 2007 - March 2010
Hills Fitness Center May 2001 - April 2009
PPD, Inc September 2005 - August 2007
3M Corporation December 2006 - May 2007
St. Edward's University May 2004 - May 2007
Self-employed February 2004 - July 2006
Skills
Recruiting, Project Management, Data Analysis, Process Improvement, Strategic Planning, Leadership, Clinical Research, Training, Change Management, Human Resources, Clinical Trials, Healthcare, Public Speaking, Management, ICH-GCP, EDC, INFORM 4.6, INFORM 5.5
Education
St. Edward's University 2004 — 2007
MBA, Global Business/Finance
Webster University 1995 — 1997
MA, Human Resource Management
University of Louisville 1985 — 1991
BA, Biology
GlaxoSmithKline March 2010 - Present
GlaxoSmithKline 2002 - March 2010
GlaxoSmithKline September 2000 - September 2002
GlaxoWellcome September 1999 - August 2000
Parexel International 1997 - 1999
Research Triangle Institute January 1995 - September 1997
Skills
Pharmaceutical Industry, Clinical Development, Clinical Research, Leadership, Clinical Trials, Project Management, GCP, Risk Management, Cross-functional Team..., Strategy, Process Improvement, Feasibility Studies, Portfolio Management, Infectious Diseases, CTMS, CRO, Drug Development, Training, Biotechnology, Line Management, Facilitation, Job Coaching, Governance
Education
North Carolina State University 1990 — 1994
Merck May 2010 - Present
Pfizer (formerly Wyeth) July 2001 - May 2010
Wyeth January 2006 - May 2009
Wyeth January 2004 - December 2005
Wyeth Pharmaceuticals July 2001 - December 2003
PAREXEL International June 1996 - June 2001
Atrix Laboratories June 1995 - June 1996
GENETICS INSTITUTE November 1988 - June 1995
POLAROID-BEHRING DIAGNOSTICS November 1987 - November 1988
Biogen Idec June 1985 - November 1987
Skills
Change Management, Project Management, Manufacturing..., Pharmaceutical Industry, Biotechnology, Validation, FDA, Drug Development, Quality Operations, Change Control, GMP, 21 CFR Part 11, CAPA, Clinical Research, CTMS, Clinical Trials, Cross-functional Team..., Medical Devices, Pharmaceutics, Process Improvement, Product Launch, Regulatory Affairs, SOP, Technology Transfer
Education
Simmons College - Simmons School of Management 1990 — 1993
MBA
Northeastern University 1980 — 1985
Bachelor of Science, Biology
PAREXEL International July 2014 - Present
Skills
Pharmaceutical Industry, FDA, GMP, CAPA, Quality System, Regulatory Affairs, Validation, V&V, Change Control, Sop, 21 CFR Part 11, GxP, Computer System..., Biotechnology, GLP, Cleaning Validation, Biopharmaceuticals, Medical Devices, Regulatory Submissions, Quality Control, Quality Assurance, HPLC, Clinical Development, Quality Auditing, Pharmaceutics, R&D, Lifesciences, Contract Manufacturing, Business Strategy, Analytical Chemistry, Clinical Trials, Regulatory Requirements, Drug Development, ISO 13485, Sterilization, LIMS, Life Sciences, SOP
Education
Pepperdine University, The George L. Graziadio School of Business and Management
MBA
Oregon State University
MS
Oregon State University
BS
Alnylam Pharmaceuticals May 2014 - Present
Cubist Pharmaceuticals November 2012 - April 2014
Research Pharmaceutical Services, Inc. January 2012 - May 2012
Broad Institute of MIT and Harvard October 2010 - December 2011
Confidential Client August 2010 - October 2010
Biomeasure/Ipsen Group Ltd. August 2009 - March 2010
PAREXEL International June 2008 - July 2009
LAB Communications, Inc. January 2001 - June 2008
Lantheus Medical Imaging June 2006 - April 2008
Vertex Pharmaceuticals August 2003 - December 2004
Skills
Clinical Trials, Pharmaceutical Industry, Medical Writing, Lifesciences, Oncology, FDA, Regulatory Submissions, Drug Discovery, Validation, Data Analysis, Regulatory Affairs, Neurology
Education
Broad Institute of MIT and Harvard 2011 — 2011
Scientific Writing
University of the Sciences in Philadelphia 2006 — 2006
Graduate, Biomedical Writing
Boston University 2005 — 2006
Medical/regulatory writing
Northeastern University 1998 — 2001
Master of Technical and Professional Writing, biomedical communications
Purdue University 1974 — 1978
BS, General Science;Biology
PAREXEL February 2009 - Present
PAREXEL International 2009 - Present
Barefoot Golf June 2008 - February 2009
Forest Laboratories January 2007 - July 2007
Pfizer July 2003 - January 2006
Millennium Pharmaceuticals June 2002 - June 2003
Hoffmann-La Roche June 1998 - May 2002
Education
The Golf Academy of America 2007 — 2008
Associate's, Golf Complex Operations and Management
Penn State University 1994 — 1998
B.S., Kinesiology
PRA Health Sciences February 2014 - Present
Quintiles April 2012 - February 2014
PPD January 2011 - April 2012
PRA International October 2010 - January 2011
Ockham Development Group (an ASG Company) October 2010 - January 2011
Kforce Clinical Research, Inc. March 2008 - August 2010
Parexel International February 2006 - March 2008
Parexel International July 2002 - February 2006
Wilbur Consulting January 2002 - July 2002
Diagnostic Clinic January 2001 - January 2002
Skills
Oncology, Rheumatoid Arthritis, Vaccines, Asthma, Dermatology, CRO, Ulcerative Colitis, EDC, CTMS, GCP, Clinical Trials, Clinical Monitoring, Psoriatic Arthritis, Clinical Development, Clinical Research, Infectious Diseases, Clinical Operations, Therapeutic Areas, Hypertension, Clinical Data Management, ICH-GCP, Patient Recruitment, Sop, FDA, Rheumatology, Endocrinology
Education
Argosy University 2007 — 2013
DBA, Leadership in International Business, All but dissertation
National-Louis University 2001 — 2003
MBA, Business Administration and Management, General
University of South Florida 1990 — 1993
MHA, Health Administration
Utica College 1972 — 1975
BS, Medical Technolgy
PAREXEL International December 2010 - Present
PAREXEL International November 2009 - Present
PAREXEL International September 2007 - November 2009
Framingham Heart Study January 2003 - August 2007
Education
Saint Anselm College 2003 — 2007
inVentiv Health August 2014 - Present
PPD October 2013 - August 2014
ICON plc May 2013 - October 2013
Quintiles, Inc October 2007 - May 2013
Johnson & Johnson October 2007 - May 2013
Coast Guard ReservesAir Station May 2002 - March 2010
Quintiles 2006 - 2009
PAREXEL 2007 - 2008
Fresenius Biotech February 2006 - October 2007
Parexel International August 2005 - February 2006
Skills
Clinical Research, GCP, CRO, Oncology, Clinical Trials, EDC, ICH-GCP, CTMS, Software Documentation, Psychiatry, Clinical Monitoring, Therapeutic Areas, Pharmaceutical Industry, Sop, Research, Clinical Development, Clinical Data Management, FDA, Therapists, Biotechnology, Diabetes
Education
Southern New Hampshire University 2014 — 2017
Master of Business Administration (M.B.A.), Business Administration and Management, General, 4.0
Worcester State College 1992 — 1996
Bachelor of Science, Psychology/Mental Health
Worcester State University 1992 — 1996
BS, Psychology
University of Massachusetts
Bachelor of Science (BS), Psychology
University of Phoenix
Masters, Management
Addivant May 2013 - Present
SK Capital Partners March 2013 - Present
PAREXEL May 2011 - December 2012
PAREXEL International May 2011 - April 2012
Vestas Wind Systems AS September 2009 - May 2011
Lean Horizons Consulting 2008 - 2009
Danaher November 1996 - January 2008
Danaher 1996 - 2008
Danaher Water Quality February 2000 - August 2005
Danaher Jacobs Vehicle Systems November 1996 - February 2000
Skills
Process Improvement, Organizational..., Continuous Improvement, Leadership, Management, Lean Manufacturing, Human Resources, Business Process, Business Development, Talent Management, Performance Management, Succession Planning, Policy, Change Management, Talent Acquisition, Employee Relations, Workforce Planning, Employee Engagement, Leadership Development, Cross-functional Team..., Organizational Design, Business Process..., Deferred Compensation, Personnel Management, Strategy, Onboarding, Organizational..., Team Management, Executive Coaching, Sourcing, HRIS, Executive Management, Strategic Planning, Mergers & Acquisitions, HR Transformation, Executive Search, Operational Excellence, Culture Change, Labor Relations, Acquisition Integration
Education
Providence College 1979 — 1983
BS, Psychology
BioMarin June 2013 - Present
Allergan April 2012 - June 2013
Vertex Data Designs September 2006 - August 2011
First Health/CCN Manage Care February 1999 - November 2003
Parexel International March 1997 - February 1999
DepoTech Corporation April 1994 - February 1997
Skills
Knowledge in SDTM, ADaM..., SAS/SQL, SAS Macros, R, SQL, Access, Java, C++, HTML, MySQL, VMS, SAS programming, SAS, SDTM, Biostatistics, Clinical Data Management, Data Management, CDISC, ODS, Statistics, S-Plus, Macro, EDC
Education
UCSD Extension 1999 — 2000
Java Language
University of California, Santa Barbara 1979 — 1982
Master, Economics
National Taiwan University 1974 — 1978
BA, Economics
PAREXEL International October 2007 - Present
Taitronics, Inc. 1990 - 2007
Skills
PowerPoint, Pharmaceutical Industry, Meeting Planning, Microsoft Excel, Event Planning, Event Management, Clinical Trials, Microsoft Office, Biotechnology, Administrative..., Clinical Research, Office Administration, Outlook, Administrative..., Data Entry, Administrative..., Management, Customer Service, Leadership, Travel Arrangements, Executive..., Travel Planning
Education
Providence College
University of Massachusetts, Amherst
B.S., Psychology
McNeil Consumer Healthcare (Johnson & Johnson) for Validant November 2012 - Present
Novartis Consumer Health for Validant April 2012 - November 2012
(Independent Consultant) November 2009 - April 2012
PAREXEL International December 2006 - July 2008
PAREXEL International November 2003 - December 2006
Skills
Pharmacovigilance, Compliance, Documentation, Clinical Data Management, Process Improvement, eCTD, 21 CFR Part 11, Regulatory Affairs, FDA, SOP, GCP, cGMP, Validation, Clinical Research, Pharmaceuticals, Medical Devices, CTMS, Biotechnology, Quality Auditing, Computer System..., Regulatory Submissions, Pharmaceutical Industry, Drug Development, GLP, Lifesciences, Technology Transfer, Sop, Quality Assurance, Quality System, CAPA, V&V, Quality Control, Change Control, GMP, Document Management, Quality Management, Software Documentation, GxP, Vaccines, LIMS, ISO, GAMP, Regulatory Requirements, R&D, ISO 13485, Clinical Trials, Clinical Development, Biopharmaceuticals, Data Management, Pharmaceutics
Education
Penn State University 1998 — 2003
BA, Technical writing/medical writing
Georgetown University
Liberal arts/languages
Independent Statistical Consultant April 2012 - Present
MAXIS IT Inc. July 2014 - December 2014
ReSearch Pharmaceutical Services November 2011 - April 2012
Parexel International April 2009 - January 2011
Wyeth March 2005 - April 2008
sanofi-aventis December 2000 - March 2005
Rhone-Poulenc Rorer, Gencell Division August 1996 - December 2000
Janssen-Ortho August 1992 - August 1996
American College of Radiology - Radiation Therapy Oncology Group June 1988 - August 1992
Skills
Senior Management, Resource Management, Budgeting, Data Management, Clinical Development, Clinical Trials, Clinical Research..., Pharmaceutical Industry, CRO, Oncology, Biotechnology, Clinical Research, Drug Development, CTMS, Regulatory Affairs, GCP, Regulatory Submissions, Lifesciences, EDC, FDA, Biostatistics, Infectious Diseases, Clinical Data Management, Immunology, Medical Writing, Protocol, Therapeutic Areas, Biomarkers, Drug Discovery, Executive Management, Pharmaceutics, Neuroscience, Management
Education
University of North Carolina at Chapel Hill 1983 — 1988
Dr.P.H., Biostatistics
University of Pittsburgh 1977 — 1979
M.S. (Hyg.), Biostatistics
City University of New York-Queens College 1973 — 1977
B.S., Biology
PAREXEL International November 2014 - Present
PAREXEL International March 2012 - November 2014
Bilcare Global Clinical Supplies June 2010 - 2011
Bilcare Global Clinical Supplies (GCS) July 2007 - June 2010
Almedica Services (now "Catalent") January 2001 - September 2005
Almedica Services Corp January 2001 - January 2002
B2BVideo Network Corporation January 2000 - January 2001
Physicians World Communications Group January 1998 - January 2000
Beacon Laboratories January 1996 - January 1998
Zambon Corporation January 1989 - January 1996
Skills
Pharmaceutical Industry, Packaging, Recruiting, Clinical Trials, Management, Logistics, Sop, Mergers & Acquisitions, Supply Chain Operations, Clinical Development, Sales, Medical Devices, Start-ups, Pharmaceutics, Quality System, FDA, Manufacturing, GMP, Supply Chain, CTMS, Process Improvement, Strategy, Healthcare, Clinical Research, Leadership, 21 CFR Part 11, Clinical Supplies, CRO, Finance, Validation, Cross-functional Team..., Key Account Management, Project Management, Oncology, New Business Development, Account Management, Supply Chain Management, Quality Assurance, GCP, Technology Transfer, Regulatory Affairs, Biotechnology, CAPA, Change Control, Contract Manufacturing, Lifesciences, Regulatory Requirements, V&V, Commercialization, Regulatory Submissions
Education
Richard Stockton College of New Jersey 1974 — 1978
Accounting
Stockton State College
Bachelor of Science Degree, Accounting
Middlesex County College
Nathan Hale /CHS
Nathan Hale /CHS
Nathan Hale /CHS
Marketing Communications Collaborative July 2007 - Present
CISCRP - Center for Information and Study on Clinical Research Participation March 2009 - May 2009
Inflexxion January 2007 - April 2007
Fallon Community Health Plan 2006 - 2006
Yankee IABC June 2000 - January 2005
PAREXEL International 2003 - 2005
Genzyme 2001 - 2003
Partners HealthCare - Newton Wellesley Hospital March 2000 - September 2000
Harvard Pilgrim Health Care 1994 - 1998
Skills
Advertising, Marketing, Healthcare, Marketing Communications, Marketing Strategy, Public Relations, Corporate Communications, Market Research
Education
Simmons College 1991 — 1994
MBA
Rhode Island School of Design 1974 — 1976
BFA
Syracuse University
PAREXEL International March 2015 - Present
GlaxoSmithKline October 2014 - February 2015
GlaxoSmithKline, Inc. November 2010 - October 2014
GlaxoSmithKline, Inc. January 2005 - November 2010
GlaxoSmithKline, Inc. May 2008 - January 2009
GlaxoSmithKline, Inc. October 2002 - January 2005
Skills
FDA, Clinical Research, Software Documentation, SOP, Training, Clinical Trials, Cross-functional Team..., Clinical Data Management, Regulatory Submissions, EDC, Protocol
Education
North Carolina Wesleyan College 2005 — 2009
Bachelor of Science, Business Administration
PAREXEL International September 2010 - Present
Davis Vision March 2010 - September 2010
BCBSNC October 2008 - March 2010
BCBSNC August 2006 - September 2008
MVP Health Care August 2004 - August 2006
MVP Health Care June 2003 - August 2004
Anthem, Inc. March 2001 - June 2003
Time Warner Cable 1998 - 2001
Skills
Management, Call Center, Performance Management, Business Analysis, Call Centers, Customer Service, Process Improvement, Project Management, Patient Recruitment, Insurance, Training, Coaching, Forecasting, Leadership, Managed Care, Visio, Interviews, Team Building, Business Process, Healthcare, Data Analysis, Change Management, Customer Retention, Health Insurance, Microsoft Excel, Leadership Development, Analysis, Cross-functional Team..., SharePoint, HIPAA, Talent Acquisition, Vendor Management, User Acceptance Testing, Contact Center..., Workforce Management, Quantitative Analytics, Contact Center..., Temporary Staffing, Quality Auditing, Resource Management, SWOT analysis, Strategic Planning, Team Leadership, Business Process..., Customer Satisfaction, Pharmaceutical Industry, Access, Strategy, Microsoft Office
Education
Pfeiffer University 2007 — 2009
Masters, Business Administration, 3.94 GPA
The College of Saint Rose 1994 — 1998
Bachelor's Degree, Public Communications, Dean's List Honors
Wingate Wealth Advisors, Inc. May 2015 - Present
PAREXEL International October 2012 - May 2015
Fisher Lynch Capital June 2007 - August 2012
Wellington Management January 2001 - June 2007
Eastern Corporate Federal Credit Union (EasCorp) February 1996 - May 2000
R.M. Bradley & Co., Inc. June 1994 - February 1996
Skills
Outlook, Customer Service, Office Management, Asset Managment, Investments, Equities, Meeting Planning, Time Management, Public Speaking, Calendars, Asset Management, Executive Office..., C-level support, Board Relations, Certified..., Banking, Benefits Administration, HR Policy Formulation
Education
Northeastern University
BSBA Management, Magna Cum Laude
Alliance HealthCare Services 2011 - Present
Manchester School District 2009 - 2011
Nypro Inc 2007 - 2009
PAREXEL International 2006 - 2007
Courier Corp 2003 - 2006
OFS (Formerly Lucent Technologies) 2001 - 2003
Engelhard Corporation (Now BASF) 1999 - 2001
THOMAS & BETTS CORPORATION 1993 - 1998
Skills
Recruiting, Employee Relations, HRIS, Performance Management, Human Resources, Employee Benefits, Change Management, Training, Leadership, HR Policies, FMLA, Personnel Management, Employment Law, Leadership Development, Policy, Management, Mergers & Acquisitions, Onboarding, Program Management, Deferred Compensation, Talent Management, Strategy, Temporary Placement, Talent Acquisition, Workforce Planning, Benefits Administration, Employee Engagement, Succession Planning
Education
Rivier College
B.S, Business Management
PAREXEL International September 1999 - Present
Skills
Neurology, Biotechnology, Vaccines, Oncology, Infectious Diseases, Clinical Research, Therapeutic Areas, Pharmaceutical Industry, Cell
Education
Penn State University 1986 — 1991
B.S, Microbiology
Jamestown HS
Jamestown HS
East Coast Clippers May 2015 - Present
Gordon College 2014 - Present
Reading Braves 2013 - Present
Andover School of Montessori 2013 - 2014
Suffolk University 2013 - 2014
PAREXEL International December 2011 - May 2013
Saint Anselm College August 2009 - May 2011
Draëger Medical Systems Inc June 2006 - August 2008
Skills
Microsoft Excel, Human Resources, Microsoft Office, Athletic Administration, Alumni Relations, Fundraising, Event Management, Relationship..., Event Planning, Donor Management, Microsoft Word, Sports Management, PowerPoint, Employee Database..., Kronos, CRM databases, Photoshop, Crystal Reports, Market Research, Data Analysis, Team Building, Cross Functional..., Advertising Operations, Marketing Operations, Interviews, Writing, Creative Writing, Content Writing, Proposal Writing, Detailed Organization, Public Speaking, Quality Assurance, Editing, Advertising, Employee Relations, Social Networking, Social Media, Marketing, Sales, Sponsorship, Brand Development, Facebook, Coaching, Press Releases, Critical Thinking, Newsletters, Research, Sports, College Recruiting, Leadership Development
Education
Saint Anselm College 2007 — 2011
Bachelor of Arts (B.A.), Communications
CalUniversity 2013 — 2014
Master of Business Administration (MBA), Finance and Financial Management Services
Array BioPharma Inc. August 2015 - Present
PAREXEL International September 2014 - August 2015
PAREXEL International July 2013 - September 2014
PAREXEL International July 2012 - July 2013
PAREXEL May 2008 - July 2012
Skills
EDC, GCP, Management, Clinical Trials, Sop, Clinical Research, CTMS, Healthcare, Clinical Operations, Project Management, CRO, Pharmaceutical Industry, Oncology, Clinical Development, ICH-GCP, Microsoft Office, Research, Biotechnology, Microsoft Excel, SOP, Clinical Data Management
Education
North Carolina Central University 1994 — 1997
Bachelor's degree, Registered Nursing/Registered Nurse
Shire Pharmaceuticals January 2015 - Present
Medivation January 2013 - January 2015
PAREXEL International June 2010 - January 2013
University of North Carolina, Chapel Hill August 2007 - June 2010
Wyeth Research January 2007 - August 2007
Genentech July 2005 - December 2006
Eli Lilly January 2004 - June 2005
Inveresk Research July 2002 - December 2003
Skills
Biostatistics, Clinical Trials, Oncology, SAS, Survival Analysis, Clinical Research, Statistical Programming, Clinical Development, CDISC, Cancer, Multivariate Analysis, Clinical Data Management, CRO, Neuroscience, Immunology, Bayesian statistics, Bid Defence, Autoimmune Diseases, Adaptive Design, NDA, Protocol Development, Leadership, Management, Protocol, Pharmaceutical Industry, Statistics, GCP, Biotechnology, EDC, Data Analysis, Life Sciences, SAS Programming, Drug Development
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Biostatistics
North Carolina State University
Master's degree, Statistics
University of Dhaka, Institute of Business Administration
Master of Business Administration (M.B.A.)
University of Dhaka
Bachelor's degree, Statistics
PAREXEL International August 2013 - December 2014
Novartis August 2012 - August 2013
TTY Biopharm August 2009 - August 2011
TTY Biopharm October 2005 - August 2009
Education
UCSC Silicon Valley Extension 2015 — 2015
Clinical Trial Design and Management Certificate Program, Clinical Study, Certificate Program
National Taiwan University 2003 — 2005
Master’s Degree, Biomedical Engineering
National Taiwan Normal University 1999 — 2003
Bachelor’s Degree, Plant Pathology and Microbiology
DOCS September 2015 - Present
PAREXEL July 2013 - Present
PAREXEL November 2011 - Present
PAREXEL International October 2007 - Present
Triple Z Ranch Pleasure Horses, LLC June 2002 - Present
Dover Saddlery November 2010 - August 2014
Skills
Outlook, Project Planning, Microsoft Excel, Customer Service, Budgets, PowerPoint, Team Building, Microsoft Word, Leadership, Microsoft Office, Human Resources, Grant Plan, Grant Manager, Budgeting, Lean Six Sigma, Supervisory Skills, Administrative Support, Customer Relations, Word, Excel, Contract Negotiation, Coordination, Promotions, Lotus Notes, Administration, Horses, Equine Facilty..., Breeding Management, Management, Training
Education
Newbury College
Newbury College
Animal Sciences
Clinverse, Inc. July 2014 - Present
Clinverse November 2011 - Present
PPD September 2007 - January 2011
PPD October 2005 - August 2007
PPD September 2001 - September 2005
Dey Pharma L.P 2000 - 2001
Cygnus 1998 - 2000
Cygnus 1997 - 1998
Parexel International 1996 - 1997
Skills
CRO, Clinical Trials, CTMS, EDC, Clinical Development, Pharmaceutical Industry, Clinical Research, Clinical Monitoring, ICH-GCP, Negotiation, Financial Services, Technology Needs..., Product Innovation, Technology Solutions, Project Management, Biotechnology Industry
Education
St. Cloud State University 1992 — 1996
BioMedical Science
NovusLife, LLC August 2015 - Present
Voisin Consulting Life Sciences June 2014 - August 2015
Voisin Consulting Life Sciences October 2012 - June 2014
Millennium: The Takeda Oncology Company August 2008 - October 2012
Millennium Pharmaceuticals August 2008 - March 2010
PAREXEL International May 2007 - August 2008
Dana-Farber Cancer Institute July 2006 - May 2007
Partners HealthCare July 2005 - July 2006
Skills
Regulatory Submissions, Regulatory Affairs, IND, Clinical Trials, Clinical Development, FDA, GCP, Pharmaceutical Industry, Oncology, Clinical Research, CTMS, CRO, ICH-GCP, IRB, Regulatory Documentation, Inflammation, NDA, Neurology, Rare Diseases
Education
Northeastern University 2007 — 2009
MS, Regulatory Affairs for Drugs, Biologics, & Medical Devices
Northeastern University 2007 — 2008
Graduate Certificate, Biopharmaceutical International Regulatory Affairs
University of New Hampshire 2000 — 2005
BA, Psychology
Regulatory Affairs Professionals Society (RAPS)
Regulatory Affairs Certification (RAC), Global Scope
Instrumentation Laboratory August 2015 - Present
Siemens Healthcare Diagnostics August 2011 - August 2015
PAREXEL International April 2010 - April 2011
CVS Pharmacy July 2005 - June 2006
Skills
GCP, Clinical Research, Clinical Trials, FDA, Regulatory Requirements, Clinical, Clinical Data Management, SOP, ICF, 21 CFR Part 11, Regulatory Affairs, 510 K, Data Collection, QC, Medical Devices, GLP, EDC, Quality Control
Education
Regis College 2009 — 2010
MS, Clinical Research
Regis College 2005 — 2009
BA, Biology
inVentiv Health May 2013 - Present
Quintiles December 2012 - May 2013
Quintiles April 2012 - November 2012
Quintiles October 2010 - April 2012
PAREXEL International April 2008 - October 2010
Asthma & Allergy Research Associates April 2006 - April 2008
St. Vincent's Catholic Medical Centers of New York June 2003 - April 2004
Skills
Clinical Research, Clinical Site Monitoring, Clinical Monitoring, ACRP, GCP, CRO, IVRS, EDC, Protocol, Regulatory Submissions
Education
Saint Vincent Catholic Medical Centres of New York 2002 — 2004
Bachelor of Science (B.Sc.), Physician Assistant
Saint John's University 1999 — 2003
Bachelors of Science, Pharmacy and Allied Health
Nassau Community College 1997 — 1999
Associates, Science
Manchester Board of Education September 2013 - Present
Bright Horizons August 2011 - July 2012
Ellis Mendel Elementary School January 2012 - April 2012
PAREXEL International December 2009 - July 2011
Mens Wearhouse May 2009 - November 2009
UConn Co-op December 2006 - September 2008
New Milford Orthopedics Associates September 2004 - August 2008
Skills
Educational Leadership, Organizational Structure, Creative Strategy, Teaching, Microsoft Office, PowerPoint, Event Planning, Social Media, Research, Microsoft Excel, Creative Writing, Microsoft Word, Outlook, Curriculum Design, Management
Education
Northeastern University 2011 — 2012
Masters in Teaching, Elementary Education, 3.9/4.0
The University of Connecticut 2005 — 2009
Bachelor of Arts in The School, Liberal Arts and Sciences; Organizational Communication Sciences, 3.3/4.0
Conatus Pharmaceuticals February 2015 - Present
Allergan, Inc February 2006 - November 2014
Santarus, Inc. October 2001 - December 2005
La Jolla Pharmaceutical April 2000 - October 2001
PAREXEL International August 1997 - April 2000
Skills
Clinical Data Management, Pharmaceutical Industry, SOP, Clinical Trials, Data Management, Clinical Development, CRO, EDC, Clinical Research, CTMS, 21 CFR Part 11, ICH-GCP, Biotechnology, Validation, GCP
Education
San Diego State University-California State University 1992 — 1996
Bachelor of Science (B.S.), Information Systems / Business Administration
Advanced Clinical August 2012 - Present
Advanced Clinical August 2003 - July 2012
Parexel International May 2002 - August 2002
Skills
Oracle Clinical, Oracle RDC, Inform, CRF design, Clinical Data Management, EDC, 21 CFR Part 11, Data Management, GCP, ICH-GCP, Clinical Trials, Clinical Research, Pharmaceutical Industry, CRO, CTMS, Medidata, Clinical Development
Education
Purdue University - Krannert School of Management 1998 — 2003
B.S., Management w/ Management Information Systems
Emery Consulting, LLC June 2009 - Present
AHEAD October 2012 - October 2013
PAREXEL International August 2005 - June 2009
Goldman Sachs May 2004 - August 2005
WorldTravel Meetings & Incentives February 2003 - May 2004
Education
Fashion Institute of Technology 1999 — 2000
Associates, Fashion Merchandise Management
South Dakota State University 1995 — 1999
Bachelor of Science
Dale Carnegie
Universovate Consulting LLC January 2011 - March 2014
Collabera-Soveriegn &IBM consulting December 2009 - March 2010
JPMorgan Chase(Strategic Staffing Solutions) December 2008 - March 2009
Parexel International May 2008 - July 2008
TIAA-CREF (CAE Solutions) January 2008 - March 2008
Fidelity Investments October 2006 - October 2007
Northeastern University & Tufts University January 2002 - December 2003
State Street Corporation January 2001 - December 2001
Fidelity Investments(Veritude) September 2000 - December 2000
Suffolk University January 2000 - August 2000
Skills
SDLC, Financial Services, Finance, Project Management, Business Analysis, Process Improvement, Strategy, Vendor Management, Fixed Income, Requirements Analysis, Business Requirements, Microsoft Excel, Portfolio Management, Asset Management, Bloomberg, Resource Management, Financial Modeling, Databases, Quality Center, PMP, Integration, Analysis, Agile Methodologies, Software Documentation, Securities, Visio, Equities, Requirements Gathering, Corporate Actions, Derivatives, Alternative Investments, Data Analysis
Education
Suffolk University - Sawyer School of Management 1999 — 2001
MBA, Finance & Information technology
Tufts University
Pharmacology & Experimental Therapeutics Internship
Northeastern University
Department of Phramaceutical Sciences Internship
Kanpur University 1992 — 1997
Bachelors
M S degree college
Bachelor's one year, (Mathematics, Physics & chemistry)
Asha Modern Public School
2years
Kendriya Vidyalaya Air Force Station Sarsawa
10 years
Montessori School Dehra Dun
Elementary Education
Greenphire October 2011 - Present
MedAvante March 2010 - September 2011
PAREXEL International March 2008 - March 2010
Veritas Medicine November 2003 - February 2008
MCS Management Services June 1995 - November 2003
Interim Services, Inc. March 1993 - May 1995
Sigma International March 1992 - March 1993
Ashland Inc July 1990 - March 1992
Skills
Sales Management, Sales, New Business Development, Client Development, Clinical Trials, Clinical Trial..., Global Business..., Strategic Sales, Major Accounts, Technology Solutions, Cross-functional Team..., Business Development, Biotechnology, Leadership, CRO, Account Management, Clinical Development, Pharmaceutical Industry, CTMS, Therapeutic Areas, EDC, Clinical Research, Clinical Data Management, Drug Development, GCP, Outsourcing, Marketing Strategy, Medical Devices, Protocol, Lifesciences, Life Sciences
Education
Penn State University 1986 — 1990
Bachelor of Science (B.S.), Marketing
North Penn High School 1983 — 1986
PAREXEL International 2006 - 2011
CHARLES RIVER LABORATORIES 2003 - 2006
PPD, Inc January 2001 - January 2003
GSK January 1999 - January 2000
METAMETRICS, Inc. January 1996 - January 1999
SmithKline Beecham Animal Health, Inc January 1992 - January 1996
Merck & Company, Inc January 1987 - January 1991
Skills
Cross-functional Team..., CRO, CRM, Pharmaceutical Industry, Business Development, Strategy, Sales, Market Research, Biotechnology, Sales Operations, Lead Generation, Infectious Diseases, EDC, Pharmaceutical Sales, Customer Relationship..., Drug Development, Strategic Sales &..., Key Account Acquisition..., B2B Sales
Education
University of North Carolina
B.A
North Carolina State University
B.S
PAREXEL International May 2013 - Present
ResolveData June 2012 - July 2013
PlumChoice May 2011 - May 2012
Comcast Cable February 2009 - December 2009
Comcast April 2008 - February 2009
Comcast August 2003 - May 2008
The TJX Companies, Inc. April 1988 - March 1996
Skills
Vendor Management, Telecommunications, Forecasting, Call Center, Process Improvement, Management, Outsourcing, Customer Experience, Project Management
Education
Southern New Hampshire University 1992 — 1996
Bachelor of Science (BS), Business Administration and Management, General
University of New Hampshire -- Peter T. Paul College of Business and Economics 1990 — 1992
BA
PAREXEL International April 2015 - Present
PAREXEL International July 2010 - April 2015
Pegasystems Inc. November 2003 - July 2010
CMGI, Inc. 1999 - 2003
Addison Wesley Longman 1996 - 1999
Houghton Mifflin Company 1994 - 1996
The MITRE Corporation 1991 - 1994
ACT 1984 - 1990
The University of Iowa 1979 - 1984
Skills
Testing, Quality Assurance, Software Quality..., Test Automation, SDLC, Test Management, Regression Testing, Agile Methodologies, Software Development, Databases, Requirements Analysis, Quality Center, Manual Testing, JIRA, Automation, HP Quality Center, SAFe, Root Cause Analysis, Innovation, Mobility Strategy, Statistics
Education
University of Iowa 1988 — 1990
B.S., Computer Science
University of Iowa 1979 — 1984
Ph.D. (ABD), Religion, History, Philosophy
Southern Methodist University 1973 — 1977
M. Th. cum laude, Theology
University of Houston 1969 — 1973
B.A., Philosophy
PAREXEL International January 2013 - September 2015
DCI Biologicals Orlando, LLC September 2007 - January 2013
APHA: Cuba Public Health Delegation November 2012 - November 2012
Orange County Health Department March 2012 - April 2012
Skills
Clinical Trials, Clinical Research, Data Analysis, Customer Service, Microsoft Excel, Microsoft Word, PowerPoint, Public Speaking
Education
Salem State University 2013 — 2013
Postgraduate Certificate, Clinical Trial Management
Nova Southeastern University 2010 — 2012
Master of Public Health (MPH), Epidemiology, 3.89
University of Central Florida 2003 — 2009
Bachelor of Science (BS), Molecular Biology & Microbiology
PAREXEL INTERNATIONAL December 2005 - Present
Aspect Software September 1996 - December 2005
Concerto Software Inc 2000 - 2005
Davox Corporation 1996 - 2000
Education
Southern New Hampshire University 1998 — 2002
MBA
University of Massachusetts Lowell 1992 — 1996
BSBA, Accounting
PAREXEL INTERNATIONAL, Billerica, Massachusetts January 2015 - Present
PAREXEL International July 2014 - December 2014
PAREXEL International April 2008 - June 2014
PAREXEL International March 2003 - April 2008
Sybase November 2001 - July 2002
Sybase November 2000 - November 2001
American Student Assistance January 1999 - November 2000
Fresenius Medical Care December 1996 - January 1999
Transition Systems, Inc. (Eclipses Software) August 1993 - September 1995
Skills
Business Intelligence, Data Governance, Master Data Management, Metadata Management, Metadata Standards, Process Improvement, Change Management, Management, Program Management, Project Management, Agile Methodologies, SDLC, Requirements Analysis, Business Objects, Integration, Business Analysis, CRM, Lead Generation, Visio, Business Process, Functional Analysis, ERP, Systems Analysis, Vendor Management, HRIS, Data Migration, User Acceptance Testing, Analysis, Data Modeling, Analytics, Data Integration
Education
Northeastern University 1983 — 1989
Bachelor of Science (BS) Business Administration, Marketing
University of Massachusetts Boston
Post graduate study
PAREXEL International August 2008 - Present
Repromedix Laboratories August 2005 - August 2008
BDSZ Company December 2003 - June 2005
Boston Medical Technologies November 1998 - November 2003
Skills
Microsoft Excel, Microsoft Office 2010, Oracle 11i, Oracle 12, Siebel
Education
Salem State University 1994 — 1998
BS
PAREXEL International September 2013 - Present
PAREXEL International December 2011 - September 2013
PAREXEL March 2008 - December 2011
Boston Scientific February 2004 - January 2008
Tufts / New England Medical Center 2001 - February 2004
Boston University School of Medicine, Department of Ophthalmology 1996 - 2001
Massachusetts Eye and Ear Infirmary, Harvard Medical School 1986 - 1996
CooperVision Pharmaceuticals, Inc 1993 - 1995
The Rockefeller University 1983 - 1986
Skills
Clinical Trials, Clinical Development, CTMS, CRO, Biotechnology, GCP, Clinical Research, ICH-GCP, Lifesciences, Pharmaceutical Industry, Protocol
Education
Mount Holyoke College
BA, Biology
Kaspersky Lab January 2015 - Present
Copyright Clearance Center October 2013 - December 2014
Analogic February 2013 - October 2013
PAREXEL International 2005 - February 2013
elephantX 2001 - 2002
biogen 1989 - 1995
Education
Wentworth Institute of Technology 1989 — 1993
Bachelor of Science (BS)
Southern Maine Community College 1985 — 1987
AS
AkzoNobel May 2015 - August 2015
USG October 2013 - May 2015
North American Corporation January 2013 - September 2013
John Crane Inc. December 2010 - December 2012
Aon Consulting October 2010 - December 2010
Challenger Gray & Christmas January 2010 - March 2010
Ossanna Consulting March 2007 - 2009
Yaskawa Electric America 2008 - 2008
ITW Paslode 2008 - 2008
Parexel International 1998 - 2005
Skills
Employee Relations, Onboarding, Human Resources, Applicant Tracking..., Personnel Management, Internet Recruiting, HRIS, Performance Management, Workforce Planning, HR Policies, Management, Recruiting, College Recruiting, Coaching, Talent Management, Talent Acquisition, Succession Planning, Temporary Staffing, Technical Recruiting
Education
Roosevelt University 2002 — 2005
Master's Degree, Human Resources Management
Janssen, Pharmaceutical Companies of Johnson and Johnson Regional Sr. Clinical Research AssociateReSearch Pharmaceutical ServicesJune 2010 - October 2012
Parexel International January 2008 - June 2010
Introgen Therapeutics April 2005 - January 2008
Westat 2002 - 2005
Medarex 1998 - 2001
Skills
CTMS, Clinical Trials, CRO, Clinical Research, Therapeutic Areas, GCP, Oncology, Clinical Monitoring, Clinical Development, EDC, ICH-GCP, Clinical Data Management, Regulatory Submissions, Clinical Operations, Oracle Clinical, Pharmaceutical Industry
Education
The George Washington University School of Medicine and Health Sciences 2008 — 2009
MSN, Clinical Research
Texas Woman's University 2003 — 2007
Seton Hall University 1993 — 1998
BS, Biology
Shire Pharmaceuticals September 2014 - Present
WorldCare Clinical, LLC January 2012 - July 2014
Parexel International September 2008 - January 2012
Perceptive Informatics August 2006 - August 2008
Perceptive Informatics August 2002 - August 2006
Phase Forward 2001 - 2002
Clinsoft 1997 - 2002
Avedis Zildjian Company 1994 - 1997
ADE 1984 - 1994
United States Marine Corps Reserve (Retired) 1976 - 1994
Skills
Quality Assurance, Engineering, Clinical Trials, Regulatory Affairs, Quality System, Pharmaceutical Industry, 21 CFR Part 11, CRO, Process Improvement, FDA, Clinical Data Management, Sop, Medical Devices, EDC, Clinical Research, Computer System..., Validation, GCP, CAPA, Cross-functional Team..., Clinical Development, Immunology, SDLC, Change Control, Project Management, V&V, Biopharmaceuticals, GMP, Clinical Monitoring, Lifesciences, Biotechnology, CTMS, ICH-GCP, Regulatory Submissions, Data Management, Drug Development, Pharmacovigilance, GxP, Oncology, Clinical Operations, GLP, Software Documentation, SOP, Life Sciences
Education
Northeastern University 1986 — 1993
Bachelor of Science (B.S.), Engineering Technology
North Quincy High School
Thesan Pharmaceuticals February 2015 - Present
Pfizer (Excaliard Pharm. Acquired by Pfizer Nov 2011) March 2012 - February 2015
PAREXEL International October 2009 - April 2011
PAREXEL International July 2008 - April 2010
The Scripps Research Institute December 2007 - June 2008
University of California January 2007 - July 2007
University of California January 1998 - January 2001
Skills
Western Blotting, Clinical Trials, PCR, Cell Biology, FDA, Clinical Research, Oncology, Data Analysis, Protein Chemistry, Purification, Gel Electrophoresis, Laboratory, Research, DNA extraction, CRM, GCP, CTMS, CRO, Clinical Development, Biotechnology, ICH-GCP, Pharmaceutical Industry, Infectious Diseases
Education
University of California, San Diego 2005 — 2007
Bachelor's degree, Pre-Medicine/Pre-Medical Studies
University of California, San Diego 2005 — 2007
B.S, Human Biology
Monterey Peninsula Community College 2004 — 2005
A.A, General
San Diego Mesa College 2003 — 2005
Associate's degree, General
Biogen Idec 2007 - Present
Alkermes 2006 - 2007
Alkermes 2001 - 2006
Biogen 1998 - 2001
PAREXEL International 1993 - 1998
Motorola Codex 1990 - 1992
Motorola Codex 1985 - 1990
Skills
Clinical Data Management, Computer System..., Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, Validation, Clinical Trials, FDA, Data Management, Sop, SAS, Clinical Development, GCP, Lifesciences, Oncology, Change Control, CTMS, Regulatory Submissions, GxP
Education
Northeastern University 1980 — 1985
BSEE, Electrical Engineering
Harvard University Extension School 1998 — 2001
Graduate Certificate, Applied Science
Wingate Healthcare March 2013 - Present
PAREXEL International March 2006 - March 2013
Skills
Financial Analysis, Strategic Financial..., Hyperion Enterprise, Financial Reporting, Financial Modeling, Analysis, Essbase, Process Improvement, Sarbanes-Oxley Act, Project Planning, Variance Analysis, Forecasting, Budgets
Education
Southern New Hampshire University 1984 — 1988
Nesher Pharmaceuticals (USA) LLC October 2014 - Present
Cedarburg Hauser Pharmaceuticals March 2013 - April 2014
PAREXEL International May 2013 - March 2014
APP Pharmaceuticals April 2006 - February 2013
Fresenius Kabi USA April 2006 - February 2013
Abraxis BioScience April 2006 - November 2007
Cardinal Health, Inc. 2000 - 2006
Aventis Behring 1997 - 2000
Fujisawa 1991 - 1997
Skills
Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, FDA, Healthcare, Lifesciences, Medical Devices, GMP, Quality System, Clinical Development, Sop, CAPA, Strategic Planning, Technology Transfer, Regulatory Affairs, Team Building, Manufacturing, Oncology, Cross-functional Team..., Management, Leadership, Quality Assurance, Validation, Process Improvement, Aseptic Processing
Education
Saint Louis University 1980 — 1985
MBA, Finance
Western Kentucky University 1972 — 1977
BS, Biology, Chemistry
Harvard University & St. Galler School of Business
International Business
Insead International Business School, Fontainebleu, France
Advanced Management Program
Shire Pharmaceuticals March 2014 - Present
Shire Pharmaceuticals December 2012 - Present
Shire Pharmaceuticals May 2010 - December 2012
Rasmussen Consultants September 2008 - March 2011
Solstice Neurosciences June 2006 - June 2008
Shire Pharmaceutical 2000 - 2006
Shire Pharmaceuticals 2000 - 2006
Parexel 1997 - 2000
PAREXEL International 1997 - 1999
Education
Southern Connecticut State University 1986 — 1989
Southern Connecticut State University 1966 — 1989
BA, Managerial Communications
Upsala College 1981 — 1983
Darien High School 1979 — 1982
Kollmorgen/Dover, a Danaher Company November 2007 - Present
Enterasys Networks 2005 - 2007
Thermo Electron Corporation March 2004 - October 2005
Teradyne, Inc August 1998 - March 2004
Parexel International July 1997 - July 1998
Intertek Testing Company September 1994 - July 1997
Raytheon Missile Systems 1987 - 1992
Skills
Budgets, Forecasting, Strategy, Managerial Finance, ERP, Finance, Analysis, SAP, Variance Analysis, Accounting, Management, Leadership, Strategic Financial..., Manufacturing, Business Analysis, Strategic Planning, Income Statement, P&L Management, Sales, Accounts Receivable, Accounts Payable, New Business Development, Cross-functional Team..., Financial Analysis, Account Management, Financial Reporting, Executive Management, Microsoft Office, Contract Negotiation, Business Development
Education
Southern New Hampshire University 1998 — 2003
MBA, Business
Northeastern University 1985 — 1992
Bachelor of Science, Accounting
PAREXEL International May 2007 - October 2007
Education
Northeastern University 2005 — 2006
MS, Regulatory Affairs
PAREXEL INTERNATIONAL March 2015 - Present
GSK 1990 - February 2015
University of North Carolina 1984 - August 1990
Skills
Public Speaking, Data Analysis, Project Management, Validation, CRO, Molecular Biology, GCP, FDA, Clinical Trials, Market Research, Biotechnology, Clinical Research, Clinical Development, Pharmaceutical Industry, Cross-functional Team..., CTMS, Oncology, Life Sciences, Regulatory Affairs, Drug Development, Regulatory Submissions, Medical Devices, Therapeutic Areas, SOP, Infectious Diseases, Team Management
Education
North Carolina State University
North Carolina State University
Master of Science (M.S.), Biology/Biological Sciences, General
MedSource January 2014 - Present
PAREXEL International March 2012 - February 2013
PAREXEL - International October 2008 - March 2012
Quintiles 1997 - 2002
Skills
Breast Cancer, Solid Tumor, Clinical Trials, Cross-functional Team..., Budgets, Project Planning, Management, EDC, Pharmaceutical Industry, CRO, Sarcoma, Acute Myeloid Leukemia, Psoriasis, Cardiology, Interventional Cardiol, Line Management, Oncology, Dermatology, Gastroenterology, Clinical Monitoring, CTMS, GCP, ICH-GCP, Drug Development, Neurology, Trial Management, Clinical Development, Clinical Operations
Education
San Diego State University-California State University 1989 — 1996
PAREXEL International February 2005 - Present
KnowledgePoint360 Group January 2000 - February 2005
Eaton Marketing Group (clients: Chrysler Corporation & Daimler-Benz) March 1998 - September 1999
RMM Record & Video Corporation (acquired by Sony Music Entertainment) August 1996 - February 1998
Skills
Marketing Strategy, Meeting Planning, Event Planning, Customer Service, Corporate Events, Sales, Project Management, Pharmaceutical Industry, Microsoft Office, Budgets, Vendor Management, Trade Shows, Microsoft Word, Incentives, Account Management, Marketing Communications, Event Management, Logistics, Strategic Planning, Leadership, Microsoft Excel, Contract Negotiation, Management, Social Media Marketing, Training, Public Relations, Program Management, Team Building, CRM, Outlook, Teamwork, Customer Satisfaction, Marketing, Negotiation, Live Events, Salesforce.com, New Business Development, Data Analysis, Access, Team Leadership, Healthcare, Hospitality, Location Intelligence, Hotels, Time Management, Recruiting, Tourism, Social Networking, CTMS, CRO
Education
Seton Hall University 1993 — 1997
Bachelor's of Arts Degree in Communications
Salamanca, Spain 1994 — 1994
Spanish
PAREXEL International November 2011 - Present
Parexel International June 2008 - November 2011
Fidelity Investments October 2004 - June 2008
Brooks Automation March 2002 - October 2004
PRI Automation August 1999 - March 2002
PRI Automation July 1995 - August 1999
Raytheon July 1986 - July 1995
Skills
Certified Scrum Master..., Requirements Analysis, Business Process, Data Conversion, Software Documentation, Process Improvement, Data Analysis, Project Management, Oracle E-Business Suite, Oracle, Business Analysis, Business Intelligence, Business Process Design, Oracle HR, Systems Analysis, Integration, Analysis, Testing, SDLC
Education
Southern New Hampshire University 1999 — 2002
MBA, Business Administration
Southern New Hampshire University 1996 — 1999
MSCIS, Computer Information Systems
Southern New Hampshire University 1994 — 1996
BSTM, Technical Management
Manchester Community Technical College 1983 — 1985
ASIE, Electronics
Quintiles January 2013 - Present
ReSearch Pharmaceutical Services July 2011 - January 2013
PAREXEL International 2007 - July 2011
PAREXEL International July 2006 - June 2007
Biosite Inc. January 2006 - July 2006
Skills
CTMS, CRO, GCP, Clinical Trials, EDC, Oncology, Clinical Monitoring, ICH-GCP, Clinical Data Management, FDA, Pharmaceutical Industry, Clinical Research, Cardiology, Biotechnology, Therapeutic Areas, Infectious Diseases, Protocol, Oracle Clinical, Sop, Regulatory Submissions
Education
San Diego State University-California State University 2000 — 2005
Bachelor of Applied Science (BASc), General Biology
University of San Diego High School 1996 — 2000
Diploma, General Studies
PAREXEL, International July 2008 - Present
PAREXEL, International June 2008 - June 2012
Medtronic August 2005 - May 2008
Skills
Clinical Trials, Clinical Development, GCP, CTMS, Clinical Operations, CRO, Clinical Research, EDC
Education
St. Catherine University
PAREXEL International 2010 - Present
IPG 2006 - 2010
Pfizer Pharmaceuticals 1997 - 2004
Berlex Laboratories 1997 - 1998
Metra Biosystems 1994 - 1996
Wyeth 1987 - 1992
Skills
Leadership, Strategy, Product Launch, Cross-functional Team..., Marketing Communications, Management, Integrated Marketing, Global Marketing, Clinical Trials, Strategic Planning, Marketing Strategy, Marketing, Healthcare, Market Access
Education
Saint Joseph's University 1981 — 1984
MBA Marketing, Pharmaceutical Marketing
Rutgers, The State University of New Jersey-Newark 1970 — 1974
BS, Medical Technology
SNBL-CPC March 2015 - Present
Long awaited and much needed sabbatical June 2013 - March 2015
Theorem Clinical Research May 2011 - May 2013
Omnicare Clinical Research 2009 - 2011
Clinimetrics Research Assoc. 2001 - 2009
PAREXEL International 1997 - 2001
Skills
Medical Devices, Pharmaceuticals, CRO, Biotechnology, Clinical Trials, Clinical Development, Research, Biopharmaceuticals, Pharmaceutical Industry, Clinical Data Management, Clinical Research, Infectious Diseases, Vaccines, CTMS, EDC, Business Development, GCP, Therapeutic Areas
Education
Penn State University
BA, Social Welfare
Penn State University
PAREXEL May 2014 - Present
PAREXEL International October 2009 - May 2014
PAREXEL May 2007 - October 2009
PAREXEL June 2005 - May 2007
PAREXEL June 2003 - June 2005
PAREXEL June 2000 - June 2003
U.S. Coast Guard September 1996 - September 2000
First Massachusetts Bank January 1999 - June 2000
First Massachusetts Bank March 1997 - January 1999
Skills
Cisco Call Manager, Integration, Vendor Management, Process Improvement, IT Management, Project Management, Cisco VoIP, Troubleshooting, Telepresence, Software Documentation, Telephony, VoIP, Telecommunications, Technical Support, Cisco Technologies
Education
Hesser College 1997 — 1999
Associate's Degree, Business Science
Pinkerton Academy 1993 — 1996
High School Diploma
University of Massachusetts at Lowell
Undergraduate Studies in Business Administration (75% Complete)
AstraZeneca Portfolio Director, PACEPAREXEL International2012 - 2014
PAREXEL International 2008 - 2011
PPD 2007 - 2008
Cogenics 2003 - 2007
Gene Logic 2000 - 2003
Johnson & Johnson 1998 - 2000
Boehringer Mannheim 1994 - 1997
Skills
Clinical Trials, Clinical Research, Strategic Planning, Pharmaceuticals, Biotechnology, CRO, Pharmaceutical Industry, Clinical Development, Management, CTMS, EDC, Process Improvement, Clinical Data Management, Drug Discovery, Lifesciences, Leadership, Product Management, GCP, Oncology, ICH-GCP, Regulatory Submissions, Drug Development, Therapeutic Areas, Infectious Diseases, 21 CFR Part 11, Clinical Monitoring, Regulatory Affairs, Sop, Clinical Operations, FDA, Protocol, Biopharmaceuticals, Pharmacovigilance
Education
New York Medical College
Biostatistics
University of Maryland College Park
Bachelor of Science, Psychology
Intersections Inc. August 2014 - Present
Intersections, Inc April 2007 - August 2014
PAREXEL September 2003 - April 2007
PAREXEL International 2003 - 2007
New York Times Shared Services Center 1997 - 2003
Skills
GAAP, General Ledger, Internal Controls, Sarbanes-Oxley Act, US GAAP, Sarbanes-Oxley, Accounting, Financial Reporting, SEC filings, Financial Analysis, Auditing, Variance Analysis, Accounts Receivable, Account Reconciliation, Mergers & Acquisitions, Financial Accounting, Managerial Finance
Education
Strome College of Business 1981 — 1985
Associates, Accounting
Old Dominion University
Old Dominion University
Old Dominion University
Old Dominion University
PAREXEL July 2012 - Present
PAREXEL International 2013 - 2015
PAREXEL July 2012 - December 2013
University of North Carolina at Chapel Hill March 2010 - July 2012
Sheraton Imperial September 2007 - March 2010
Skills
Front Office, Hospitality, Hospitality Management, Hotels, Hospitality Industry, Hotel Management, Micros, Rooms Division, Resorts, Revenue Analysis, Specimen Collection, Drawing Blood, Patient Recruitment, Document Review, Study Start Up
Education
North Carolina Agricultural and Technical State University 2002 — 2006
Bachelor of Arts (B.A.), Speech-Language Pathology/Pathologist
PAREXEL May 2012 - Present
PAREXEL International 2010 - Present
International Partnership for Microbicides 2010 - 2011
PAREXEL September 2001 - April 2009
American Red Cross 1993 - September 1999
American Red Cross, Biomedical Services 1993 - 1999
Skills
Change Control, FDA, Quality Assurance, Sop, Quality System, GMP, Pharmaceutical Industry, Medical Devices, Quality Auditing, V&V, Regulatory Requirements, CAPA, Regulatory Affairs, Computer System..., Pharmaceutics, Validation, SOP, 21 CFR Part 11
Education
Slippery Rock University of Pennsylvania 1970 — 1974
BS, education
PAREXEL May 2015 - Present
PAREXEL April 2012 - Present
PAREXEL International April 2008 - July 2012
Perceptive Informatics, a PAREXEL Company September 2006 - April 2008
Target Software, Inc January 2006 - August 2006
Senior-Systems, Inc August 2004 - January 2006
Vision Appraisal Technology August 2003 - August 2004
Education
Northeastern University 2001 — 2003
MS; Diploma, Information Systems
Shippensburg University of Pennsylvania 1995 — 1999
BA Mathematics, Diploma, Operations Research
Biotech/ Pharma/ CRO/ Medical Device Companies May 2015 - Present
Pharmaceutical July 2014 - May 2015
PAREXEL International October 2012 - July 2014
Parexel International 2010 - 2012
PPD September 2008 - September 2010
i3 Research May 2006 - May 2008
Parexel International February 2005 - May 2006
Quintiles September 2004 - February 2005
Parexel International March 2003 - September 2004
Skills
Clinical Trials, EDC, CRO, Clinical Research, Analysis, Project Management, Management, Data Entry, Training, Contract Management, Databases, Program Management, GCP, ICH-GCP, IRB, Clinical Study Design, Clinical Data Management, Data Management, Clinical Development, Pharmaceutical Industry
Education
North Carolina Central University 1988 — 1993
MLS, Library and Information Science
North Carolina Central University 1985 — 1988
BS, Health Education
1241 Inc. 2000 - Present
PAREXEL International March 2003 - June 2010
Pfizer (formely known as Pharmacia/Monsanto Searle) October 1999 - January 2002
Salem Services, Inc September 1998 - October 1999
Champion Technologies, Inc August 1996 - September 1998
Skills
FDA, Public Speaking, Clinical Trials, Oncology, Clinical Research, CRO, Therapeutic Areas, Pharmaceutical Industry, Training, Validation, Type 2 Diabetes, CTMS, Sop
Education
Northwestern University 1992 — 1997
B.S.I.E., Industrial Engineering
Northwestern University
Bachelors of Science, Industrial Engineering
Cranbrook Kingswood
Alvine Pharmaceutical June 2013 - Present
AMO January 2010 - June 2013
AMO January 2010 - July 2012
Revance Therapeutics January 2009 - June 2009
Exelixis September 2007 - January 2009
PAREXEL International 2001 - 2007
Skills
Clinical Trials, Clinical Monitoring, Clinical Operations, ICH-GCP, Medical Devices, Regulatory Affairs, Regulatory Submissions, Cardiology, Therapeutic Areas, Ophthalmology
Education
San Diego State University-California State University
BS, Nutrition and Food Science
Parexel International May 2013 - Present
PAREXEL February 2012 - Present
KBI Biopharma November 2011 - January 2012
Eisai Inc 2009 - April 2011
Gorbec Pharmaceutical services 2008 - 2009
Johnson & Johnson May 2007 - June 2008
Skills
GLP, Biotechnology, Formulation, Management, Pharmaceutical Industry, Clinical Trials, Validation, CRO, GMP, Sop, FDA, Time Management, Oncology, Clinical Research, Regulatory Affairs, Data Management, Medical Devices, R&D, Data Analysis, Project Management, Business Strategy, Six Sigma, Forecasting
Education
North Carolina State University - College of Management 2011 — 2013
MBA, BioScience and Supply Chain Management, GPA:3.8
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2007
BSc, Biotechniology
Boston Scientific March 2010 - Present
Boston Scientific April 2003 - March 2010
PAREXEL International 1989 - 2003
Education
Northeastern University 1982 — 1985
MS, Pharmacology
Alcon Labs July 2013 - March 2014
PRA International December 2012 - September 2013
OptumInsight August 2012 - March 2013
PAREXEL International August 2010 - July 2012
PAREXEL International August 2010 - July 2012
Carolinas Medical Center March 2009 - September 2010
Carolinas Medical Center March 2009 - September 2010
PPD, Inc July 2007 - July 2010
Skills
CTMS, EDC, CRO, Clinical Monitoring, Clinical Trials, ICH-GCP, Clinical Research, Endocrinology, GCP, Inform, Protocol, Regulatory Affairs, Sop, Therapeutic Areas, Clinical Data Management, Clinical Development, Rheumatology, Dermatology, Clinical Operations, Oracle Clinical
Education
North Carolina Agricultural and Technical State University 1995 — 2000
BS, Nursing
North Carolina Agricultural and Technical State University 1995 — 2000
BS, Nursing
North Carolina Agricultural and Technical State University
BS, Nursing
'Self-Employed' July 2015 - Present
Self Employed March 2014 - Present
L'Oreal USA November 2013 - May 2014
Pfizer Inc August 2010 - May 2012
PAREXEL International July 2007 - August 2010
Faulkner Hospital June 2006 - September 2006
University of Massachusetts, Lowell December 2005 - June 2006
Skills
clinical trial, Customer Service, GCP, CTMS, Regulatory Documentation, Process Improvement, Clinical Monitoring, Analytical Approach, Vendor Relations, CRA, TMF, Microsoft Office, Information Management, Quality Assurance, Regulatory Requirements, Technical Writing, Writing, Creative Writing, eTMF, Clinical Trials, Pharmaceutical Industry, ICH-GCP, Software Documentation, CRO, EDC, FDA, Clinical Development, IRB
Education
New York University 2011 — 2013
Master of Science (M.S, Business Strategy and Leadership
University of Massachusetts at Lowell 2003 — 2007
Bachelor of Science (B.S, Clinical Laboratory Sciences
Contract July 2015 - Present
Lantheus Medical Imaging September 2014 - July 2015
Telerx (formerly Sentrx) December 2012 - September 2014
AMAG Pharmaceuticals July 2012 - October 2012
Cell Therapeutics, Inc. November 2011 - June 2012
EMD Serono August 2010 - November 2011
Averion International October 2009 - August 2010
PAREXEL International March 2007 - October 2009
SkinCare Physicians October 2005 - March 2007
Boston EMS 1995 - October 2005
Skills
Clinical Trials, GCP, Regulatory Affairs, Pharmaceutical Industry, Pharmacovigilance, Clinical Research, Oncology, Clinical Development, CTMS, FDA, Drug Safety, CRO, Biotechnology, Sop, Medical Devices, Cardiology, 21 CFR Part 11, Biopharmaceuticals, Clinical Data Management, Clinical Operations, Drug Development, GLP, GxP, ICH-GCP, IND, Infectious Diseases, MedDRA, Medical Affairs, Medical Writing, Medicine, Neurology, Pharmaceutics, Regulatory Submissions, Therapeutic Areas, SOP
Education
Northeastern University 2008 — 2010
MS, Regulatory Affairs for Drugs, Devices, and Biologics
PAREXEL International January 2008 - Present
New Path Creative, LLC 2007 - Present
Harris Interactive January 2000 - December 2007
Kraus LeFevre Studios Inc. 1996 - 2000
Rochester Institute of Technology 1996 - 1998
Matrix Unlimited 1993 - 1996
Skills
Adobe Creative Suite, Web Design, Graphic Design, Interaction Design, Marketing Communications, Packaging, Creative Direction, User Experience, Logo Design, Brand Development, Art Direction, Photography, Email Marketing, Direct Mail, Integrated Marketing, Website Development, Photoshop, Advertising, Illustrator, Copywriting, Graphics
Education
Rochester Institute of Technology 1988 — 1992
Bachelor of Fine Arts (BFA), Graphic Design
ProNAi Therapeutics September 2015 - Present
PAREXEL May 2010 - September 2015
PAREXEL International July 1999 - June 2008
Fournier Pharma February 1996 - July 1999
Toronto General Hospital 1993 - 1999
Toronto Western Hospital 1987 - 1993
North York General Hospital 1985 - 1987
Skills
Clinical Research, CRO, GCP, Clinical Development, Clinical Trials, CTMS, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, EDC, Medical/Surgical, Pediatrics, Diabetes, ICU, Regulatory Submissions, Project Management
Education
York University - Joseph E. Atkinson Faculty of Liberal and Professional Studies 1989 — 1990
BAS, Business Administration
Seneca College of Applied Arts and Technology 1983 — 1985
Nursing, Nursing
Eisai April 2013 - Present
PAREXEL International March 2012 - April 2013
Pharmaceutical Product Development, Inc. (PPD) August 2011 - March 2012
Merck & Co. Inc. February 2011 - August 2011
Clinpharm Clinical Research LLC October 2009 - February 2011
Education
New York University 2008 — 2010
Master's degree, Electrical and Electronics Engineering, A
PAREXEL International 2011 - Present
FDA 2008 - 2011
Ceptor, Inc. 2004 - 2007
Johnson & Johnson PRD 2002 - 2004
3DP 1998 - 2001
The Scripps Research Institute 1992 - 1994
Skills
Regulatory Affairs, Drug Discovery, Biotechnology, Lifesciences, Pharmaceutical Industry, Chemistry, Protein Chemistry, Drug Development, Analytical Chemistry, Biopharmaceuticals, Clinical Development, Clinical Trials, FDA, Purification, Regulatory Submissions, Life Sciences
Education
Rice University
Ph.D., Biochemistry
FORUM Pharmaceuticals June 2013 - Present
PAREXEL International October 2008 - June 2013
Smith Hanley Consulting Group September 2007 - June 2008
GE Healthcare September 2007 - 2008
PPD February 2005 - September 2007
Duramed/Barr Research Inc March 2003 - February 2005
RHO, Inc March 2001 - February 2003
New England Medical Center February 2000 - March 2001
Massachusetts Department of Public Health January 1993 - January 1996
Masschusetts Department of Public Health January 1992 - January 1993
Skills
SAS programming, Protocol, Validation, Data Management, Statistics, Research, Data Collection, Project Management, Quality Control, Database Design, Report Writing, Specifications, Clinical Trials, CRO, SAS, Biostatistics
Education
University of Massachusetts, Amherst 1997 — 2000
Master of Science, Biostatistics
Salem State University
Bachelor of Science, Economics
PAREXEL INTERNATIONAL September 2012 - Present
Skills
Pharmaceutical Industry, Biotechnology Industry, CRO, ICH-GCP, GCP, CTMS, SOP, EDC, FDA, EMEA, Clinical Development, Clinical Research, Clinical Trials, Clinical Monitoring, Therapeutic Areas, Oncology, CNS disorders, Dermatology, Pharmacovigilance, Infectious Diseases, Lifesciences
Education
Université Laval 1989 — 1992
M.Sc., Experimental Medicine
Université du Québec à Trois-Rivières 1991 — 1992
Bachelor of Science (B.Sc.), Medical Biology
Université du Québec à Montréal 1985 — 1988
B.Sc., Biochemistry
College de Rosemont 1982 — 1985
DEC, Universal Sciences 015
Royal Military College of Canada/Collège militaire royal du Canada 1981 — 1982
Académie Michèle Provost 1976 — 1981
DES, High School/Secondary Diplomas and Certificates
PAREXEL November 2014 - Present
PAREXEL November 2012 - November 2014
PAREXEL November 2010 - August 2011
PAREXEL International March 2007 - October 2010
PAREXEL November 2005 - March 2007
Skills
Clinical Operations, CRO, Clinical Development, EDC, Clinical Trials, CTMS, Clinical Data Management, GCP, ICH-GCP, Clinical Research, Pharmaceutical Industry, Clinical Monitoring, Biotechnology
Education
Saint Michael's College 2001 — 2005
BS, Biology, Journalism
Aerotek Scientific February 2015 - Present
Salix Pharmaceuticals (Aerotek Scientific) August 2013 - February 2015
Health Decisions January 2007 - August 2013
Health Decisions February 2005 - January 2007
PAREXEL International January 2003 - January 2005
PAREXEL International July 1999 - January 2003
Skills
Clinical Research, Sop, IND, EDC, Clinical Trials, FDA, Inform, Regulatory Affairs, GCP, CRO, CTMS, Clinical Data Management, ICH-GCP, Clinical Monitoring, Therapeutic Areas, Protocol, SOP
Education
North Carolina Wesleyan College 2002 — 2005
Business Administration
Shaw University 1996 — 1997
Sociology
PAREXEL International February 2013 - Present
Becton Dickinson - Biosciences August 2010 - March 2012
Becton Dickinson - Women's Health and Cancer January 2006 - August 2010
Central Coast Primary Care January 2003 - November 2005
Cytology Laboratories June 1988 - November 1997
Clinical Labs January 1976 - November 1985
Skills
GCP, Sop, Laboratory, Medical Diagnostics, Recruiting, Data Collection, System Monitoring, Training, Phlebotomy, Teaching, Start-ups, Coordination, Troubleshooting, Editing, Clinical Trials, Clinical Research, EDC, ICH-GCP, Protocol, Biotechnology, CRO, Pharmaceutical Industry, SOP, Life Sciences, Oncology, Infectious Diseases, Clinical Development
Education
Antioch New England Graduate School 1987 — 1990
Master of Education (M.Ed)
Cytotechnologist 1980 — 1981
CT ASCP, Cytology
University of Colorado 1980 — 1981
Electron Microscopy/ Micro Anatomy
Southern Illinois University, Carbondale 1973 — 1975
BS, Zoology
ReSearch Pharmaceutical Services October 2012 - Present
PAREXEL International November 2010 - October 2012
PAREXEL International December 2009 - October 2010
Massachusetts General Hospital September 2007 - December 2007
Skills
Clinical Research, Medical Research, Clinical Trials, IRB, GCP, CTMS, Oncology, Clinical Monitoring, EDC, ICH-GCP, CRO, Clinical Development, Informed Consent, Trial Management
Education
Regis College 2009 — 2011
Master's degree, Regulatory and Clinical Research Management
Regis College 2005 — 2009
Bachelor's degree, Biology
PAREXEL INTERNATIONAL December 2009 - Present
BIOSCIENCES (Becton Dickinson) January 2008 - November 2009
DANIS PROPERTIES, LLC November 2007 - January 2008
MELMARK NEW ENGLAND, INC March 2007 - August 2007
EASTERN DEVELOPMENT, LLC July 2002 - January 2007
BROOKS INTERIORS GROUP, INC March 2000 - July 2002
GETRONICS (formerly Wang Laboratories) August 1996 - March 2000
Skills
MS Office (Word, Excel,...
Education
NORTHEASTERN UNIVERSITY
B.S
Northern Essex Community College
A.S
Sanofi April 2014 - Present
Sanofi January 2013 - Present
Sanofi December 2011 - December 2012
Genzyme October 2009 - February 2012
Genzyme Corporation May 2000 - September 2009
Parexel International April 1998 - May 2000
Skills
Process Improvement, Project Management, Clinical Trials, Clinical Development, Cross-functional Team..., Clinical Research, Regulatory Affairs, Program Management, Change Management, Medical Devices, Management, Data Management, Regulatory Requirements, Pharmaceutical Industry, Project Planning, CDISC, GCP, 21 CFR Part 11, Protocol, Biotechnology, Strategy, FDA, Oncology, SAS programming, CTMS, Regulatory Submissions, EDC, Healthcare, CRO, Drug Development, Lifesciences, Clinical Data Management, Analysis, Integration
Education
University of Massachusetts at Lowell 2012 — 2014
Master of Science in Health Informatics and Management, Health Informatics
Northeastern University
BSN, Nursing
Tufts University
BSEE, Electrical Engineering
Pharmaceuticals June 2014 - Present
Johnson and Johnson, Mentor, LLC March 2013 - March 2014
Naval Medical Center San Diego April 2010 - February 2013
PAREXEL International July 2008 - June 2009
Allergan Medical November 2006 - August 2008
UCSD Moorse Cancer Center, La Jolla, CA August 2006 - November 2006
Institute of Health Care Assessment October 2005 - August 2006
BioMed IRB January 2005 - October 2005
San Diego State University August 1995 - July 1998
San Diego State University July 1994 - June 1998
Skills
GCP, Clinical Trials, IRB, Clinical Research, CRO, EDC, Pharmaceutical Industry, Regulatory Affairs, Therapeutic Areas, Trial Management, Regulatory Submissions, ICH-GCP, Clinical Monitoring, CTMS, Inform, Medical Devices, Asthma, Lifesciences, Protocol, Phase I, Research, Allergy, CRF design, Clinical Research..., Science, COPD, Patient Recruitment, Oracle Clinical, Clinical Data Management, Clinical Development, Oncology, Medical Writing, Infectious Diseases, Clinical Study Design, Dermatology
Education
San Diego State University-California State University 1995 — 1998
Graduate School, Psychology, 3.68
San Diego State University-California State University 1992 — 1995
BA, Psychology, 3.72
PAREXEL International November 2011 - Present
PAREXEL October 2009 - October 2011
PAREXEL April 2008 - September 2009
Skills
Inform, EDC, CTMS, ICH-GCP, Clinical Trial..., GCP, CRO, Rheumatoid Arthritis, Endocrinology, Diabetes, Hypertension, Cardiology, Clinical Research
Education
Rajiv Gandhi University of Health Sciences 2001 — 2006
BPharm, Pharmacy
Novartis Vaccines 2014 - Present
Shire Human Genetic Therapies Inc. (Shire HGT) 2011 - 2014
Shire Human Genetic Therapies, Inc (Shire HGT) 2004 - 2011
Parexel International 1998 - 2004
Astra USA, Inc 1979 - 1998
Westwood Pharmaceuticals 1977 - 1979
Invenex Pharmaceuticals 1975 - 1977
Skills
Regulatory Affairs, Pharmaceutical Industry, Drug Development, Strategy, CMC, Chemistry, Management, Microbiology, Business Process..., Regulatory Submissions, FDA, Biotechnology, Clinical Development, GMP, Clinical Trials
Education
Niagara University 1973 — 1976
MS, Natural Sciences/Biology
Niagara University 1969 — 1973
BS, Natural Sciences/Biology
Clinical Quality Assurance Services, LLC 2011 - Present
Biovail Technologies, Ltd September 2002 - January 2011
Parexel International June 1998 - September 2002
Otsuka America Pharmaceutical Inc. June 1995 - May 1998
Skills
Sop, GLP, IT Audit, Protocol Review, GCP, CRO, CSR, Clinical Development, Quality Assurance, Pharmacovigilance, Drug Development, CAPA, Quality System, Clinical Trials, Biotechnology, Regulatory Requirements, Pharmaceutical Industry, SOP, FDA
Education
Penn State University
B.S., Animal BioScience
PAREXEL International November 2014 - Present
PAREXEL International May 2013 - October 2014
PAREXEL International October 2011 - May 2013
Premier Research Group September 2008 - October 2011
Self Employed Service Provider February 2002 - December 2010
UCB Pharma June 2007 - September 2008
UCB Pharma January 2006 - June 2007
UCB Pharma January 2004 - January 2006
UCB Pharma September 2003 - January 2004
BodyBlitz January 2000 - January 2002
Skills
Clinical Development, CRO, Clinical Research, Clinical Trials, Oracle Clinical, Clinical Data Management, Oncology
Education
University of Southern Mississippi 1997 — 1999
Master of Science, Exercise Physiology
Millsaps College 1992 — 1994
Bachelor of Arts, English
Merck June 2015 - Present
Cubist Pharmaceuticals December 2014 - June 2015
DUSA Pharmaceuticals Inc. a Sun Pharma Company August 2011 - December 2014
PAREXEL International 2007 - 2011
Skills
GMP, Strategic Sourcing, Pharmaceutical Industry, Supply Management, FDA, ISO 13485, CAPA, Process Improvement, Quality System, Cross-functional Team..., Procurement, Sop, ISO, Six Sigma, SOP, Leadership, Management, Biotechnology
Education
Rivier College 2009 — 2012
Master of Business Administration (M.B.A.), Business Administration and Management, General, 3.9
Rivier College 2004 — 2008
Bachelor of Science, Business Administration
PAREXEL International April 2010 - Present
Blaire House of Tewksbury November 2006 - April 2010
Genesis Rehabilitation Services December 1998 - November 2006
Skills
Personnel Management, HRIS, Benefits Administration, Human Resources, Employee Relations, Employee Benefits, Performance Management, Management, Talent Acquisition, Applicant Tracking..., Training
Education
Middlesex Community College
Associate's degree, Liberal Arts and Sciences/Liberal Studies
North Reading High School
PAREXEL International June 2014 - Present
PAREXEL International October 2010 - June 2014
QIAGEN December 2001 - May 2010
Skills
Biotechnology, Pharmaceutical Industry, Clinical Trials, CRO, FDA GMP, GLP, GCP, SAP Implementation, QAQC, QAD, Change Control, Medical Diagnostics, Molecular Diagnostics, 21 CFR Part 11
Education
Penn State University 1977 — 1981
Bachelor's Degree, Medical Technology/Microbiology Specialist