PAREXEL International Corporation
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, MA CEO: Jamie Macdonald (Mar 15, 2018–) Number of employees: 19,000 Founder: Josef H. von Rickenbach Founded: 1982 Subsidiaries: ClinPhone Inc, ClinPhone Ltd,
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PAREXEL International Corporation Employees
Genentech July 2014 - Present
Genentech September 2013 - July 2014
Sunovion Pharmaceuticals Inc. June 2012 - August 2013
Sunovion Pharmaceuticals Inc. March 2012 - June 2012
Sunovion Pharmaceuticals Inc. (formerly Sepracor) July 2010 - March 2012
Sepracor February 2009 - July 2010
Sepracor November 2007 - February 2009
PAREXEL International Corporation September 2005 - November 2007
AnchorPoint January 2005 - September 2005
Skills
Strategic Planning, Digital Marketing, Managed Care, Product Launch, Market Research, Cross-functional Team..., Cross-functional..., Business Development, Vendor Management, Online Marketing, Email Marketing, Direct Mail, Television, Television Production, DTC, Segmentation, Media Planning, Website Management, Website Redesign, SEM, SEO, Print Collateral, Packaging, Manufacturing, Speakers Bureau, Advisory Boards, Contract Negotiation, Contract Review, Agency Agreements, Agency Negotiations, Financial Management
Education
Bentley University 2001 — 2005
Bachelor of Science, Marketing
Trumpolt Compensation Design Solutions June 2012 - Present
Deutsche Post November 2011 - May 2012
DHL Express Americas May 2010 - October 2011
DHL Express United States March 2006 - April 2010
DHL Express United States March 2005 - March 2006
AutoNation, Inc January 2002 - March 2005
Trendium, Inc January 1999 - January 2002
Nova Southeastern University January 1998 - January 1999
Parexel International Corporation January 1995 - January 1998
Skills
Global and Executive..., Market Analysis and..., Certified Employee..., Job Evaluation..., Sales Incentive Plan..., Job Architecture and..., Compensation Training..., Employee Retention..., Salary Survey Management, Policy Development, Competency Modeling, Client Compensation..., Deferred Compensation, Performance Management, Human Resources, Policy, Employee Engagement, Personnel Management, Employee Value..., Leadership Development, Incentive Programs, Employee Benefits, Compensation & Benefit, Job Evaluation, Change Management, Talent Management, Executive Pay, Payroll, Strategy, Leadership, Management, Succession Planning, Salary, Compensation Structures, HRIS, Compensation & Benefits
Education
Framingham State University 1993 — 1996
Master of Arts, Human Resources Management
Nichols College 1983 — 1986
Bachelor of Science, Public Administration
inVentiv Health Clinical December 2014 - Present
PAREXEL International Corporation November 2011 - November 2014
INC Research LLC April 2010 - November 2011
INC Research LLC January 2009 - April 2010
INC Research LLC August 2007 - January 2009
Skills
GCP, CTMS, Clinical Trials, Sop, Recruiting, Human Resources, CRO, ICH-GCP, Regulatory Affairs, Regulatory Submissions, Therapeutic Areas, Regulatory Requirements, 21 CFR Part 11, IRB, Protocol, SOP
Education
Southeastern College 1989 — 1992
Psychology
Broward College
Fidelity Investments January 2004 - Present
Fidelity Investments January 2004 - Present
CMGI Inc. November 2001 - January 2004
CMGI Inc November 2001 - January 2004
ExperionSystems.com December 2000 - July 2001
MotherNature.com August 2000 - November 2000
Cross Country Group November 1999 - July 2000
Parexel International Corporation November 1996 - November 1999
Education
Bentley College 1992 — 1996
BS, Computer Information Systems
Bentley University 1990 — 1994
Bachelors, CIS
Middlesex Community College
Associates Degree, Business Administration
PAREXEL International Corporation March 2015 - Present
Pixtronix, Inc. a Qualcomm Company December 2012 - December 2014
Sentillion, Inc. March 2011 - December 2012
BAE Systems April 2007 - September 2010
Cubist Pharmaceuticals October 2006 - April 2007
kSARIA Corporation August 2005 - August 2006
Formatech, Inc. November 2000 - August 2005
Bio-Rad Laboratories January 1999 - November 2000
General Signal Networks October 1995 - January 1999
Thermo Electron Tecomet March 1994 - October 1995
Skills
Accounting, Hyperion Enterprise, QuickBooks, Microsoft Excel, SAP, Income Statement, Oracle, Information Technology, Cognos, Peachtree, Great Plains Software, Purchasing, Management, Process Improvement, Account Reconciliation, Financial Analysis, Microsoft Dynamics GP, Hyperion, Forecasting, Financial Reporting, Analysis, Budgets, Internal Controls
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1991 — 1994
MBA, Accountancy
University of Massachusetts, Amherst 1985 — 1988
BBA, Bachelor of Business Administration, Graduated Cum Laude
Good Neighbor Concierge June 2011 - Present
Family Nurturing Center April 2011 - June 2011
The Home for Little Wanderers January 2010 - March 2011
U.S. Census Bureau - Department of Commerce March 2009 - May 2009
PAREXEL International Corporation February 2003 - September 2004
PAREXEL International Corporation July 1999 - February 2003
Hebrew Rehabilitation Center for Aged September 1997 - July 1999
Newton-Wellesley Hospital October 1996 - September 1997
Deaconess Stat Temps August 1996 - October 1996
Virginia Center for Orthopaedics August 1994 - August 1996
Skills
Customer Service, Keyboarding, Data Management, Writing, Listening to customers, Resourceful in the..., Track Record Of..., High Quality Standards, Self-motivated Team..., Problem Solving, Close Attention to..., Volunteer Management, Management, Small Business, Community Outreach, Editing, Professional Organizing, Administrative..., Office Management, Nonprofits, Event Management, Fundraising, Time Management, Organizational Structure, Entrepreneurship, Blogging, Pet Sitting, Social Media, Social Networking, Data Entry, Healthcare, Administrative Work, Senior Services, Social Media Marketing, Organizational..., Coaching, Errands, Leadership, Personal Shopping, Event Planning, Running Errands, Concierge Services, Public Speaking, Newsletters, Facebook
Education
Clark University
Webmaster Certificate Program
Northeastern University
Technical Writing Certificate Program
Computer Dynamics Institute - Career Education Center 1993 — 1994
Medical Transcription/Medical Secretary Diploma Program
Old Dominion University 1989 — 1994
Bachelor of Science (B.Sc.), Sports Medicine
PAREXEL International Corporation July 2012 - Present
PAREXEL International Corporation January 2007 - July 2012
PRA International April 2006 - December 2006
PAREXEL International Corporation March 2003 - April 2006
Rhote Research February 1998 - March 2003
Skills
Clinical Monitoring, GCP, Clinical Trials, CTMS, ICH-GCP
Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 1984 — 1986
BS, Medical Technology
Alfred State College - SUNY College of Technology 1981 — 1983
AAS, Medical Lab Technlogy
OBI Pharma, Inc March 2014 - Present
Idenix Pharmaceuticals, Inc. September 2000 - September 2013
PAREXEL International Corporation 1993 - August 2000
GH Besselaar/ICP June 1988 - December 1992
Skills
Regulatory Affairs, Drug Development, IND, Clinical Trials, FDA, Regulatory Submissions, GCP, Pharmaceutical Industry, Biotechnology, Clinical Development, Oncology, Quality Assurance, Clinical Research, Regulatory Requirements, CRO, Sop, Infectious Diseases, eCTD, Label negotiations, Clinical Hold..., NDA/MAA, CTA, PMDA, SFDA, EMA, GMP, GLP
Education
University College Dublin 1971 — 1975
BSc, Ph.D., Biochemistry, Pharmacology
Vertex Pharmaceuticals August 2015 - Present
Vertex Pharmaceuticals September 2011 - Present
Outcome Sciences November 2010 - September 2011
Averion International November 2007 - October 2010
Averion international Corp December 2002 - November 2007
PAREXEL January 2000 - December 2002
Parexel International Corporation July 1998 - January 2000
PAREXEL June 1996 - July 1998
Skills
Clinical Trials, Oncology, GCP, Clinical Trial..., Clinical Research, Strategic Planning, Clinical Data Management, Contract Negotiation, CRO, Life Sciences, Process Improvement, Change Management, Budget Management, Compliance, Cross-functional Team..., Mergers, Pharmaceuticals, Outsourcing, Operations Management, Clinical Development, EDC, CTMS, Lifesciences, Drug Development, Clinical Monitoring, Biotechnology, Healthcare, Pharmaceutical Industry, Validation, Budgets, Infectious Diseases, Sop, Mergers & Acquisitions, 21 CFR Part 11, Protocol, Oracle Clinical, Data Management, FDA
Education
University College London, U. of London 1992 — 1996
Biotechnology BSc (Hons)
Dulwich College
Accenture February 2015 - Present
City of Oakland November 2014 - Present
CSC- General Dynamics Electric Boat July 2014 - Present
Aerojet Rocketdyne July 2014 - October 2014
Passaic Valley Sewerage Commission, NJ April 2013 - June 2014
Capgemini January 2012 - April 2013
Accenture Consulting USA December 2010 - December 2011
Power Engineers August 2010 - November 2010
Motorola November 2009 - July 2010
PAREXEL International Corporation June 2008 - July 2009
Skills
Oracle E-Business Suite, Oracle Applications, Financials, Oracle, Oracle HR, Data Migration, Vendor Management, SDLC, Program Management, Integration, Business Process, Software Documentation, Business Intelligence, Requirements Analysis, Procure-to-Pay, ERP, Business Analysis, Consulting, Solution Architecture, Software Project..., Project Management, Management
Education
Hemwati Nandan Bahuguna Garhwal University 1991 — 1994
B.Com, Accounting
PRA International August 2013 - Present
PRA International January 2004 - August 2013
SCIREX Corporation July 2001 - December 2003
PRA International June 1999 - October 2000
Clinicor Incorporated July 1996 - June 1999
Berlex Laboratories June 1995 - July 1996
Parexel International Corporation June 1994 - June 1995
Parexel International Corporation June 1993 - June 1994
Parexel International Corporation June 1993 - June 1994
International Clinical Research Corporation (Division of Quintiles) June 1991 - June 1993
Skills
IRB, Oncology, Clinical Trials, GCP, Therapeutic Areas, Clinical Development, Clinical Research, Drug Development, FDA, Phase I, Protocol, Regulatory Submissions, CRO, CTMS
Education
Bishop Montgomery 1987 — 1991
Occidental College 1987 — 1991
BA, Biology
PAREXEL International Corporation July 2013 - Present
Selsoft Inc., November 2012 - June 2013
Alere, Inc. November 2012 - May 2013
Tata Consultancy Services July 2012 - November 2012
AIG January 2007 - November 2012
Tata Consultancy Services July 2010 - June 2012
Tata Consultancy Services October 2006 - June 2010
Skills
PEGA Certified Senior..., PEGA Certified System..., PEGA Certified Business..., PEGA Certified..., Sun Certified Java..., Sun Certified Web..., Sun Certified Business..., Sun Certified Java..., PL/SQL, SOA, JSP, Java Enterprise Edition, Struts, Pega PRPC, Oracle, Pegasystems PRPC, Core Java, Requirements Analysis, DB2, SDLC, Websphere, JavaScript, Servlets, Weblogic, Agile Methodologies, Java, Web Services, Software Project..., SQL
Education
University of Massachusetts Lowell 2015 — 2020
Master of Business Administration (MBA), Innovation and Entrepreneurship
Jalpaiguri Government Engineering College 2002 — 2006
B.TECH., Electronics & Communication Engineering, DGPA : 8.94 out of 10
Cora Operations Inc. December 2011 - Present
PNL Accounting Services September 2009 - Present
F.E.C. Inc November 2006 - July 2009
Jay Cashman Inc November 2005 - November 2006
Parexel International Corporation May 2001 - November 2005
Novell Inc October 2000 - April 2001
State Street Research & Mgt April 2000 - October 2000
Iron Mountain Inc April 1999 - April 2000
Safety 1st Inc. January 1997 - April 1999
Safety 1stInc. July 1996 - January 1997
Skills
Cash Management, Accounting, Financial Reporting, Forecasting, Cash Flow, Payroll, Accounts Payable, Accounts Receivable, Quickbooks, Excel, General Ledger, Microsoft Office, Reconciliation, Variance Analysis, Outlook, Account Reconciliation
Education
University of Massachusetts Boston 1992 — 1996
B.S., Accounting
Westwood High School 1983 — 1987
Diploma
Aegerion Pharmaceuticals 2013 - Present
Puffin Advisors, LLC January 2011 - 2013
Ascent Venture Partners July 2009 - November 2011
PAREXEL International Corporation July 2008 - July 2010
AstraZeneca Pharmaceuticals November 2003 - September 2007
AstraZeneca Pharmaceuticals January 1998 - November 2003
AstraZeneca Pharmaceuticals November 1993 - December 1997
Martin Marietta (Formally General Electric Aerospace) January 1992 - November 1993
General Electric Aerospace January 1990 - December 1992
Unisys Corporation 1989 - 1990
Skills
Agile, Applications Support, Business Continuity, Benefits Realisation, Business Strategy, CDISC, Change Management, Cloud Computing, COBIT, Computer Hardware, Computer Security, Computer System..., Corporate Management, CTMS, Data Center Architecture, Data Center Relocation, Distributed Team..., EDC, ePro, Executive Management, Functional Management, Global Deployment, Health Information..., High Availability, High Performance Systems, Imaging, IT Benchmarking, ITIL, IT Management, IT Operations, IT Outsourcing, Internet Systems, IT Transformation, Leadership Development, M&A experience, Management Consulting, Medical Records, Military Leadership, Managed Services, Object Oriented Design, Organizational..., Product Assessment, Project Coaching, SAS70, Security, Security Policy..., SOX, Strategic Assessment, Strategic Leadership, Storage Consolidation
Education
Trinity University 1978 — 1981
Computer Science
University of California, Berkeley 1973 — 1977
B.S., Electrical Engineering & Computer Science
Novartis Institutes for BioMedical Research March 2012 - Present
PROMETRIKA January 2010 - March 2012
PROMETRIKA May 2004 - February 2010
Genzyme Pharmaceuticals, Inc March 2002 - January 2004
Muro Pharmaceuticals, Inc March 2001 - March 2002
PAREXEL International Corporation February 1999 - March 2001
PAREXEL 1999 - 2001
Skills
Clinical Trials, EDC, GCP, Data Management, CDISC, Clinical Data Management, CRF design, Oncology, Clinical Monitoring, Lifesciences, CRO, Data Validation, CTMS, 21 CFR Part 11, Oracle Clinical
Education
Saint Michael's College 1994 — 1998
BS, Environmental Science
Mantick Life Sciences Consulting, LLC May 2014 - Present
NovusLife, LLC July 2014 - Present
PAREXEL International May 2011 - April 2014
Abt Bio-Pharma Solutions, Inc. 2006 - 2010
Genzyme 1998 - 2006
PAREXEL International Corporation 1994 - 1998
Arthur D. Little, Inc. 1988 - 1992
The Upjohn Company 1984 - 1988
Skills
Clinical Research, Strategy, Cross-functional Team..., Leadership, Program Management, Healthcare, Biopharmaceuticals, Business Development, Market Access, Lifesciences, Management, Outcomes Research, Pharmacovigilance, Training, Clinical Development, CRO, Public Health, Drug Development, Pharmaceutical Industry, Oncology, Vaccines, Regulatory Affairs, Biotechnology, GCP, New Business Development, Talent Management, Clinical Data Management, Clinical Study Design
Education
Harvard University School of Public Health 1992 — 1994
SM, Health Policy and Management
University of Kentucky 1979 — 1984
BS, Pharmacy
SynteractHCR August 2015 - Present
Monitor for Hire June 2015 - August 2015
Monitor for Hire June 2015 - August 2015
Monitor for Hire November 2014 - February 2015
PAREXEL July 2012 - November 2014
Mid-South Monitoring Inc July 2006 - September 2013
Monitor for Hire February 2012 - July 2012
Therapeutic Experience February 2003 - December 2010
PAREXEL International Corporation May 2005 - July 2006
PRA International February 2003 - May 2005
Skills
GI, Oncology, Clinical Trials, Neurology, Cardiology, Clinical Research, Clinical Monitoring, Electronic Data Capture..., CTMS, Endocrinology, Gastroenterology, Infectious Diseases, Data Management, FDA, Chronic Illness, CRO, Inform, Pharmaceutics, Pharmaceutical Industry, Diabetes, Protocol, Dermatology, GCP, EDC, Sop, Hematology, Regulatory Affairs, Vaccines, Clinical Development, Rheumatology, Biotechnology, Women's Health, ICH-GCP, Cell, Allergy, Pain Management, SOP
Education
Hendrix College 1984 — 1988
BA
Little Rock Catholic High School 1980 — 1984
SciQuus Oncology May 2015 - Present
ClinDART, Inc. June 2012 - April 2015
Pfizer Inc December 1999 - April 2012
Pfizer Inc April 2002 - December 2005
Agouron Pharmaceuticals, Inc, A Pfizer Company April 2001 - April 2002
Agouron Pharmaceuticals, Inc December 1999 - April 2001
Ligand Pharmaceuticals, Inc December 1998 - December 1999
PAREXEL International Corporation May 1997 - December 1998
Clinical Research Specialists January 1996 - April 1997
Skills
Clinical, Team Leadership, Team Management, Staff Development, Change Management, Clinical Research, Leadership, Oncology, Clinical Trials, Management, CTMS, Cross-functional Team..., GCP, Software Documentation, Project Management, Clinical Monitoring, EDC, Clinical Development, Drug Development, CRO, Sop, FDA, SOP
Education
Loyola Marymount University 1990 — 1994
B.A, Biology
TSS Consulting Ltd. April 2005 - Present
JW Technical Recruiting Associates April 2005 - Present
LTX Corporation 1999 - 2005
Parexel International Corporation October 1992 - October 1996
LTX-Credence Corporation 1988 - 1992
aritech corp 1984 - 1988
15th Medical Batallion 1st Cavalry Div, US Army April 1969 - April 1970
Skills
Technical Recruiting, Talent Acquisition, Applicant Tracking..., Sourcing, Recruiting, Semiconductors, Talent Management, Employee Relations, Onboarding, Human Resources, Temporary Placement, College Recruiting, Workforce Planning, Executive Search, Performance Management, Personnel Management, Employee Engagement, Management, Internet Recruiting, IC, Contract Recruitment, Interviews, Electrical Engineering, Leadership, Screening Resumes, Succession Planning, Staffing Services, Hiring, Screening, Start-ups, Executive Management, SDLC, Career Development, Resume Writing, Deferred Compensation, Employee Benefits, Cold Calling, HRIS, Employee Training, HR Consulting, Executive Coaching, Strategy, Training, Leadership Development
Education
Boston University 1974 — 1976
MS, Clinical Social Work
Boston College 1971 — 1974
BA, Sociology/Psychology
Cushing Academy 1963 — 1965
H.S. Diploma, N/A
Premier Research March 2015 - Present
Randstad Pharma January 2015 - March 2015
Premier Research July 2014 - January 2015
Premier Research Group February 2012 - January 2015
Kelly Services and PPDI January 2011 - April 2012
The Write Edge April 2010 - January 2011
Rho, Inc. May 2007 - March 2010
PAREXEL International Corporation November 1999 - May 2007
PAREXEL International Corporation November 1996 - November 1999
BRI International April 1995 - November 1996
Skills
Clinical Development, Medical Writing, Regulatory Submissions, Protocol, Clinical Research, Clinical Study Design, IND, Therapeutic Areas, Medical Devices, CRF design, Training, Medicine, Editing, Management, GCP, CRO, Clinical Trials
Education
University of Alabama 1979 — 1983
BA, political science and English
AbbVie June 2010 - Present
The University of Chicago January 2007 - January 2009
NorthShore University HealthSystems January 2006 - January 2007
PAREXEL International Corporation January 2005 - January 2006
NorthShore University HealthSystems January 2005 - January 2006
NorthShore University HealthSystems January 2003 - January 2005
NorthShore University HealthSystems January 2002 - January 2003
Skills
Access, Outlook, Research, Excel, PowerPoint, Word, Administration, Budgeting, Microsoft Office, Contract Management, Customer Service, Problem Solving, Healthcare, Hospitals, Administrative Support, Scheduling, Database Administration, Visiontracker, SharePoint, Administrative...
Education
Oak Lawn Community High School 1989 — 2002
General Equivalence Diploma
South Suburban College
UCB Pharma 2001 - August 2015
PPD September 1999 - May 2001
Quintiles April 1999 - August 1999
PAREXEL International Corporation August 1997 - March 1999
Morton Plant Mease 1994 - 1997
University of South Florida - College of Medicine 1985 - 1994
Skills
Clinical Trials, EDC, Clinical Data Management, GCP, CRO, Pharmaceutical Industry, CRF design, Oracle Clinical, ICH-GCP, MedDRA, Clinical Development, CTMS, 21 CFR Part 11, Sop, Project Data Management, Patient Centricity, Timeline Management, SOP
Education
University of South Florida 1991 — 1993
Master of Business Administration (M.B.A.), Quality Improvement, Information Systems, Finance, 3.85 GPA
University of South Florida 1981 — 1986
Bachelor of Science (B.S.) - Biology, Pre-Medicine/Pre-Medical Studies, Cum Laude
Energetic Professional Seeking New Title January 2015 - Present
ACORN Research LLC May 2009 - November 2009
ICON Clinical Research December 2007 - May 2009
Harrington College of Design September 2002 - November 2007
Weiss Memorial Hospital September 2000 - January 2002
Parexel 1999 - 2002
Parexel International Corporation September 1999 - September 2000
University of Chicago April 1997 - September 1999
Skills
Analysis, Project Planning, PowerPoint, Software Documentation, Management, Data Analysis, Human Resources, Access, Microsoft Office, Clinical Trials, Healthcare, Time Management, Customer Service, Leadership
Education
Benedictine University 2000 — 2003
Associate of Arts, Business Administration
Moraine Valley College
Certified Nursing Assistant
University of Chicago Hospitals
PAREXEL International Corporation June 2014 - Present
AbbVie Pharmaceuticals February 2013 - November 2013
Abbott Laboratories February 2012 - February 2013
BioSante Pharmaceuticals, Inc. 2011 - 2012
Lundbeck 2010 - 2011
Abbott Laboratories July 2007 - January 2010
Abbott Laboratories July 2005 - July 2007
Biovail 2002 - 2003
Caremark Specialty Pharmacy 1998 - 2002
Education
Webster University 2007 — 2010
Master's, Business Administration
St. Louis Community College 1989 — 1991
Associate's, Nursing
Eastern Illinois University 1982 — 1985
Bachelor's, Business - Marketing and Economics
Truven Health Analytics April 2012 - Present
Microsoft 2010 - March 2012
Thomson Reuters April 2007 - June 2010
Perceptive Informatics, Inc. January 2005 - May 2007
Perceptive Informatics, Inc. August 2000 - January 2005
PAREXEL International Corporation September 1998 - August 1999
PAREXEL International Corporation March 1998 - August 1998
PAREXEL International Corporation October 1997 - March 1998
Perceptive Systems, Inc. April 1993 - September 1997
Summit Labs 1990 - 1993
Skills
SDLC, Software Development, Data Management, SQL, Databases, Database Design, Medical Imaging, Agile Methodologies, Scrum, Integration, Enterprise Architecture, Requirements Analysis, Microsoft SQL Server
Education
University of Colorado Boulder 1983 — 1986
MS, Computer Science
Colorado College 1978 — 1982
BA, Mathematics
Novartis June 2011 - Present
Alkermes June 2008 - May 2011
IPSEN, Biomeasure, Inc March 2007 - June 2008
Dana-Farber Cancer Institute February 2006 - March 2007
Dana-Farber Cancer Institute July 2003 - February 2006
Dana-Farber Cancer Institute July 2003 - April 2005
Health Policy Associates, Inc March 2003 - July 2003
PAREXEL International Corporation April 2002 - March 2003
Beth Israel Deaconess Medical Center September 2001 - April 2002
Dana-Farber Cancer Institute June 1999 - June 2001
Skills
Clinical Research, Oncology, Regulatory Affairs, Clinical Trial..., CTMS, Clinical Data Management, Clinical Trials, Clinical Monitoring, Clinical Operations, Clinical Development, Biotechnology, Sop, Lifesciences, Clinical Study Design, Protocol, SOP
Education
Massachusetts College of Pharmacy and Health Sciences 2005 — 2007
MS, Drug Regulatory Affairs and Health Policy
University of New Hampshire 1994 — 1999
BS, Nutritional Sciences
Beitak co. June 2013 - January 2015
CORRONA, Inc. February 2012 - May 2013
Shire HGT August 2010 - September 2011
Shire HGT August 2009 - August 2010
PAREXEL International Corporation February 2008 - May 2009
PAREXEL International Corporation June 2007 - February 2008
Baystate Clinical Research January 2005 - November 2005
Sentient Medical Systems September 2002 - October 2004
The University of Massachusetts September 2001 - May 2002
Skills
Clinical Trial..., Clinical Research, GCP, Clinical Trials, Clinical, ICH-GCP, Clinical Development, Regulatory Affairs
Education
The University of Sydney, School of Public Health 2005 — 2006
Masters of Science, International Public Health; Health Projects Management; Applied Biostatistics
University of Massachusetts, Amherst 1998 — 2002
Bachelors of Science, Biology; Neuroscience
PAREXEL International Corporation December 1997 - Present
Skills
Pharmaceutical Industry, Clinical Trials, Pharmacovigilance, CRO, Regulatory Affairs, GCP, Clinical Development, Clinical Research
Education
Bentley University
GlaxoSmithKline January 2007 - August 2008
GlaxoSmithKline January 2002 - January 2007
PAREXEL, International Corporation March 2001 - January 2002
PAREXEL International Corporation October 1998 - March 2001
Skills
Cross-functional Team..., Pharmaceutical Industry
Education
University of Maryland University College 2000 — 2005
MSM/HCA, Healthcare Administration
University of the District of Columbia 1982 — 1984
B. Sc, Computer Information Systems Science
University of the District of Columbia 1973 — 1978
B. A., Biology
SHEPARD PUBLIC RELATIONS & MARKETING GROUP January 2009 - Present
Cabot Corporation 2000 - 2008
Parexel International Corporation January 1997 - January 1999
Blue Cross and Blue Shield of MA 1993 - 1997
WCVB-TV 5 January 1989 - January 1993
Skills
Media Relations, Marketing Communications, Public Relations, Press Releases, Business Strategy, Strategic Planning, Internal Communications, Event Management, Brand Management, Newsletters, Marketing, B2B, Product Development, Crisis Communications, Publicity, Product Launch, Marketing Strategy, New Business Development, Marketing Management, Corporate Branding
Education
Boston University
BS
Simmons College
Sierra Consulting Group, Inc October 1994 - Present
Ardea Biosciences 2008 - 2012
PAREXEL International Corporation January 1994 - October 1994
Burroughs Wellcome Co. August 1991 - January 1994
Burroughs Wellcome Co. June 1990 - August 1991
Burroughs Wellcome Co. March 1987 - May 1990
Duke University Medical Center April 1986 - March 1987
Lineberger Cancer Research Center September 1984 - May 1986
Skills
CRO, CTMS, Clinical Monitoring, Clinical Development, GCP, Clinical Trials, Regulatory Submissions, Oncology, Infectious Diseases, Protocol, Sop, Biotechnology, Clinical Research, FDA, Pharmaceutical Industry, Quality Assurance
Education
University of North Carolina at Chapel Hill
M.S, Biostatistics
Rochester Institute of Technology
B.S, Applied Mathematics
PAREXEL International Corporation March 2014 - Present
PAREXEL International Corporation August 2007 - February 2014
Streitboerger Speckmann June 2001 - May 2006
Court of Appeals (Kammergericht) Berlin May 1999 - April 2001
Skills
Legal Research, Privacy Law, Litigation, Pharmaceutical Industry, Employment Law, Legal Writing, Lifesciences, Contract Negotiation, European Law, Life Sciences, Regulatory Affairs, Legal Advice, CRO, Clinical Trials, GCP, Legal Compliance, Dispute Resolution, Patents, Regulatory Submissions, Clinical Development, Corporate Law, FDA, Biotechnology, CTMS
Education
Boston University School of Law 2006 — 2007
Master of Laws (LL.M.)
Rheinische Friedrich-Wilhelms-Universität Bonn 1993 — 1998
Law Degree (JD equivalent), Law
PAREXEL International Corporation December 2001 - Present
Education
Aurora University
PRA International November 2011 - Present
Tragara Pharmaceuticals September 2007 - September 2011
Dow Chemical Company April 2005 - August 2007
PAREXEL International Corporation June 2002 - March 2005
PAREXEL International Corporation October 2000 - May 2002
STATPROBE October 1999 - July 2000
Skills
CRO, Clinical Trial..., Oncology, Pharmaceuticals, Clinical Research, Biotechnology, Data Management, GCP, Clinical Data Management, Project Management, Pharmaceutical Industry, CTMS, EDC, Clinical Monitoring, ICH-GCP, Clinical Trials, Clinical Development
Education
Webster University 2000 — 2003
MBA, Business Administration
University of California, Davis 1993 — 1997
B.S, Environmental and Resource Science
Indivior Inc August 2012 - Present
Daiichi Sankyo, Inc. October 2007 - August 2012
Bayer HealthCare April 2005 - October 2007
sanofi-aventis October 1997 - April 2005
Parexel International Corporation June 1996 - November 1997
Skills
Outcomes Research, Pricing, Sales Operations, Managed Care, Market Access, Health Economics, Pharmaceutical Industry, Clinical Trials, Cardiology, Medical Affairs, Sales Effectiveness, Strategy, Cross-functional Team..., Clinical Development, Clinical Research, Pharmaceutical Sales, Pharmaceutics, Oncology, Medical Devices, Regulatory Affairs, Leadership
Education
Thomas Jefferson University 1995 — 1996
Fellowship
The University of Georgia 1993 — 1995
Masters
Kakatiya University 1988 — 1992
Bachelors (RPh)
Jefferson School of Population Health
Certificate
St. Paul's School
St. Paul's School
St. Paul's School
PAREXEL International Corporation September 2013 - June 2014
PAREXEL International Corporation June 2000 - August 2013
UB Vehicle Leasing, Inc. (a subsidiary of BTM Capital Corporation) December 1998 - May 2000
BTM Capital Corporation December 1995 - December 1998
Caremark International, Inc. November 1993 - December 1995
Whirlpool Financial Corporation September 1991 - November 1993
Whirlpool Financial Corporation September 1989 - September 1991
Skills
Managerial Finance, Mergers & Acquisitions, Leadership, Mergers, Auditing, Finance, Accounting, Business Strategy, Restructuring, Management, Budgets, Financial Analysis, Sarbanes-Oxley Act, Acquisition Integration, Due Diligence, Strategic Planning, Corporate Finance, Pharmaceutical Industry, Financial Modeling, Credit, Financial Reporting, Risk Management, Forecasting, Revenue Recognition, General Ledger, Executive Management, Influence Without..., Strategic Financial..., New Business Development, Financial Planning
Education
Syracuse University - Martin J. Whitman School of Management 1966 — 1973
BS/MBA, Finance and Accounting
TrueTandem March 2011 - Present
PRM Consulting March 2010 - March 2011
Ajilon Consulting June 2009 - July 2009
International Monetary Fund April 1996 - May 2009
Travelers October 1994 - April 1996
PAREXEL International Corporation July 1988 - October 1994
McDonald's Corporation 1980 - 1993
Egghead Software 1989 - 1991
American Legislative Exchange Council 1986 - 1988
Skills
SharePoint, Cloud Computing, Office 365, Enterprise Architecture, Knowledge Management, IT Strategy, Integration, Enterprise Software, System Center, Windows Server, SCCM, Project Management, Microsoft Office, Visio, Microsoft Technologies, Microsoft SQL Server, ITIL, Business Analysis, Management, Program Management, PMP, IT Service Management, Strategy, Data Center, Security, IT Management, Vendor Management, Leadership, Networking, Windows 7, System Deployment, XP, VMware, Software Documentation, Information Technology, Business Process, Citrix, Business Intelligence, Hyper-V, Disaster Recovery, SDLC, Solution Architecture, Project Portfolio..., Hardware, Architecture, Requirements Analysis, Windows, SaaS, Consulting, Enterprise Content...
Education
Bridgewater College 1979 — 1986
BA, History and Political Science
George Mason University
PAREXEL International Corporation March 2015 - Present
GlaxoSmithKline 2012 - 2015
GlaxoSmithKline 2006 - 2012
GlaxoSmithKline 2004 - 2006
GlaxoSmithKline 2001 - 2004
Skills
Project Portfolio..., Pharmaceutical Industry, Clinical Development, Process Improvement, CTMS, Project Management, Drug Development, Program Management, MS Project, Strategic Planning
Education
University of North Carolina at Chapel Hill
At home 2000 - Present
PAREXEL International Corporation April 1989 - 2000
Fisons Corporation 1987 - 1989
Arthur D. Little 1985 - 1987
Education
Ohio Wesleyan University 1977 — 1981
BA, Zoology (Art minor)
MedImmune April 2011 - September 2015
MedImmune April 2009 - April 2011
Wyeth Research April 2007 - April 2009
Wyeth Research May 2005 - April 2007
Quintiles December 2003 - May 2005
PAREXEL International Corporation 1999 - 2003
Spherion 1997 - 1999
Skills
Oncology, Leadership, Infectious Diseases, Vaccines, Clinical Trials, Therapeutic Areas, Business Strategy, Program Management, Clinical Research, Clinical Development, Strategy, Biotechnology, Gastroenterology, Management, Pharmaceutical Industry, Contract Management, Sop, Outsourcing, CRO, GCP, EDC, Neuroscience, Clinical Data Management, CTMS, FDA, Drug Development, Sourcing, Drug Discovery, Neurology, ICH-GCP, Technology Transfer, Validation, Cardiology, Regulatory Submissions, Cross-functional Team..., Clinical Monitoring, Immunology, Endocrinology, Medical Devices, Medical Writing, GLP, Regulatory Affairs, GMP, Lifesciences, Protocol, Pharmacovigilance, Training, Biopharmaceuticals, Clinical Operations, 21 CFR Part 11
Education
University of Massachusetts, Amherst 2006 — 2008
Business administration
Duke University 1992 — 1996
Bachelor, French, Mathematics
Université Denis Diderot (Paris VII) 1994 — 1995
Mediaeval French
Takeda Pharmaceuticals July 2014 - June 2015
Synta Pharmaceuticals May 2012 - July 2014
Synta Pharmaceuticals May 2010 - May 2012
Netherlaggen Ranch March 2008 - June 2009
Antigenics July 2006 - September 2007
New England Aquarium September 2004 - September 2007
Battelle CRO January 2005 - September 2005
Wyeth October 2003 - September 2004
PAREXEL INTERNATIONAL CORPORATION March 2002 - October 2003
Omnicare October 2001 - January 2002
Skills
Clinical Trials, Oncology, Oracle Clinical, Clinical Research, FDA, Protocol, Data Management, CRF design, CRO, Clinical Development, GCP, Veterinary Medicine, Marine Mammals, International Travel, Pharmaceutical Industry, Clinical Data Management, Drug Development, Validation, ICH-GCP, MedDRA, Lifesciences, CDISC, EDC, Biotechnology, Immunology, Inform, 21 CFR Part 11, Medical Devices, GMP, Scuba Diving, Virology, Veterinary Pathology, Regulatory Submissions, CTMS, Medical Writing, Clinical Study Design
Education
Glasgow University 2007 — 2010
Veterinary Medicine
Harvard University 2011 — 2012
Biochemistry and Molecular Biology
Northeastern University 2003 — 2004
Neurobiology and Anatomy
Southampton College 1999 — 2000
BS, Interdisciplinary Biology/Psychology
University of West Florida 1997 — 1998
Marine Biology and Biological Oceanography
University of Massachusetts, Amherst 1995 — 1995
Tropical ecology in Anguilla
Allergan, Inc ManagerPAREXEL1994 - 2004
PAREXEL International Corporation 1994 - 2004
Education
University of Massachusetts Lowell
Self Employed February 2014 - Present
ViiV Healthcare December 2011 - July 2013
Clinilabs August 2010 - December 2010
Duke Clinical Research Institute May 2007 - July 2010
Quintiles International Corporation November 2000 - March 2005
Quintiles International Corporation February 2000 - November 2000
Quintiles International Corporation December 1998 - February 2000
Quintiles International Corporation December 1997 - December 1998
PAREXEL International Corporation March 1997 - December 1997
PAREXEL International Corporation May 1996 - March 1997
Skills
Clinical Trials, Process Improvement, Strategy, Clinical Research, Biotechnology, Leadership, Management, Business Development, Proposal Writing, CRM, Lifesciences, CRO
Education
North Carolina Wesleyan College 1993 — 1995
B.S, Business Administration
BSBA
Bachelor of Business Administration (B.B.A.)
Fonville Morisey
The Write Angle, LLC 1999 - Present
Rhone-Poulenc Rorer 1995 - 1998
Parexel International Corporation 1991 - 1995
Skills
Medical Writing, Regulatory Submissions, Clinical Study Reports, Protocol Development, Oncology, Cardiology, Infectious Diseases, Neurology, Clinical Study Design, Clinical Development, Protocol, Pharmaceutical Industry, FDA, Clinical Trials, Clinical Research, Therapeutic Areas
Education
Boston University School of Medicine
MPH
Massachusetts College of Pharmacy and Health Sciences
BS
PAREXEL International Corporation October 2009 - Present
PAREXEL January 2003 - September 2009
PAREXEL October 1990 - December 2002
PAREXEL July 1986 - August 1990
SYNTEX Pharmaceuticals October 1978 - December 1985
Education
University of Michigan
Ph.D., Toxicology
Optimer Pharmaceuticals 2011 - Present
Harbor BioSciences, Inc. (formerly Hollis-Eden Pharmaceuticals) January 2006 - April 2011
Hollis-Eden Pharmaceuticals July 2002 - December 2005
PAREXEL International Corporation 1998 - 2002
PAREXEL International Corporation 1995 - 1998
PAREXEL International Corporation 1991 - 1995
PAREXEL International Corporation 1987 - 1991
Skills
Clinical Data Management, Clinical Trials, Data Management, CRF design, Sop, Clinical Research, Phase I, EDC, CRO, GCP, Pharmaceutical Industry, Biotechnology, Clinical Study Design
Education
Bridgewater State University
BS, Education
SIRTEX March 2014 - Present
Aeris Therapeutics September 2012 - November 2013
Shire HGT August 2011 - May 2012
Biogen Idec May 2011 - June 2011
NxStage Medical, Inc December 2007 - April 2011
PAREXEL International Corporation April 2001 - December 2007
PAREXEL International Corporation January 1998 - January 2001
PAREXEL International Corporation January 1997 - January 1998
Skills
ICH-GCP, Clinical Research, Clinical Trials, Pharmaceutical Industry, GCP, FDA, Sop, Clinical Data Management
Education
Boston University 2008 — 2010
Clinical Research Certificate
New Hampshire Community Technical College 1995 — 1999
Diploma, Medical Assistant
Prospect Clinical Research, Inc. June 2010 - Present
PAREXEL International Corporation May 2006 - October 2009
Parexel International 2006 - 2009
PPD International Corporation December 2004 - May 2006
Xandoyne Pharmaceuticals April 2003 - December 2004
Eli Lilly (Kelly Services) April 2000 - May 2002
Skills
GCP, Clinical Trials, FDA, CRO, Protocol, Regulatory Affairs, Clinical Research, Quality Assurance, CRF design, CTMS, Clinical Monitoring, ICH-GCP, EDC, Clinical Development, Clinical Data Management, Therapeutic Areas, Infectious Diseases, Inform
Education
Indiana University-Purdue University at Indianapolis 1999 — 2003
BS, Life Sciences
Indiana University 1995 — 2000
B.S; A.S, Life Sciences
Strategic Solutions Division of PRA Health Sciences September 2012 - Present
RPS Strategic Solutions, a subsidiary of PRA International February 2012 - September 2012
Novartis Pharmaceuticals January 1999 - February 2012
Novartis January 2006 - January 2008
Romac International January 1997 - January 1999
Covance March 1997 - August 1997
PAREXEL International Corporation January 1994 - January 1997
Clinical Aid Pharmacy Corporation January 1994 - January 1996
Alpha Therapeutic Corporation January 1992 - January 1994
Glendale Memorial Hospital January 1989 - January 1992
Skills
EDC, Clinical Monitoring, GCP
Education
Loyola Marymount University 1986 — 1991
BACHELOR OF SCIENCE, BIOLOGY
Duke Clinical Research Inst., Duke University June 2008 - Present
Duke University May 2004 - June 2008
Duke University March 2003 - May 2004
Duke University June 2000 - March 2003
PAREXEL International Corporation January 1997 - January 2000
MarkeTech Systems January 1995 - January 1997
Wayne State University January 1990 - January 1995
Skills
Data Management, Clinical Trials, Data Analysis, SAS, CRO, EDC, Process Improvement, Drug Development, Cross-functional Team..., Databases, Pharmaceutical Industry, Validation, Protocol, FDA, Project Management, Sop, Software Documentation, Clinical Data Management, Clinical Research, 21 CFR Part 11, Management, GCP, Clinical Development, Infectious Diseases
Education
Michigan State University
B.S, Biological Sciences
Wayne State University
M.B.A, Finance
PAREXEL International Corporation October 1982 - Present
Skills
CRO, Drug Development, Clinical Research, Clinical Development, Pharmaceutical Industry, Clinical Trials, Biotechnology Industry, CTMS, Biotechnology, Regulatory Affairs, Oncology, Vaccines, Pharmaceuticals, Clinical Trial..., General Management, Entrepreneurship, Corporate Strategy..., Board Governance, Board of Directors, New Venture Development, Business, International Business, Global Management, IT Management
Education
Harvard Business School 1979 — 1981
MBA
University of Applied Sciences, School of Business, Lucerne, Switzerland
B.A., Business Economics
RadPharm, Inc. 2005 - 2010
Broom Street Associates 2005 - 2006
Bruce Rogers Company 2001 - 2006
Stat-Trade, Inc. 2004 - 2004
Children’s Clinical Research Institute 2002 - 2003
Adolor Corporation 1999 - 2001
Sanofi-Synthelabo 1998 - 1999
Biosyn, Inc. 1998 - 1998
Premier Research Worldwide 1996 - 1997
PAREXEL International Corporation 1993 - 1995
Education
La Salle University
BA, Psychology, Biology
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
RTI-Health Solutions October 2007 - Present
BIOPHARMACEUTICAL QUALIFICATIONS June 2003 - Present
Drug Safety Alliance June 2004 - October 2007
Drug Safety Alliance 2004 - 2007
PAREXEL International Corporation January 2003 - February 2004
Education
State of North Carolina Board of Nursing
Master's, Research
University of North Carolina at Chapel Hill
Master of Science; School, Nursing; Nursing; Information and Library Science
Nazareth College
Bachelor of Science, Nursing
I.M. Behavioral Health Services, LLC January 2009 - March 2011
BOGIER Clinical and IT Solutions, Inc June 2010 - February 2011
PPD April 2004 - July 2009
Parexel International Corporation July 1999 - March 2004
Quintiles January 1999 - June 1999
Duke University Medical Center Trauma Services January 1999 - March 1999
The Durham Center February 1994 - December 1998
Guilford County Mental Health Center - Willie M Program May 1990 - January 1994
Skills
Recruiting, Clinical Research, Human Resources, Clinical Trials, Mental Health, Oncology, Training, Policy, Clinical Monitoring, Healthcare, Protocol, CRO, Data Management
Education
North Carolina Central University 1997 — 1999
Master of Arts, Psychology
University of North Carolina at Greensboro 1987 — 1991
Bachelor of Arts, Psychology
Janssen, Pharmaceutical Companies of Johnson and Johnson August 2013 - Present
Janssen Scientific Affairs, Johnson & Johnson June 2011 - August 2013
Ortho-McNeil Janssen Scientific Affairs, Johnson & Johnson January 2007 - June 2011
PriCara, Unit of Ortho-McNeil Pharmaceuticals, Johnson & Johnson January 2005 - January 2007
Janssen Pharmaceutica, Johnson & Johnson March 2003 - January 2005
Janssen Pharmaceutica, Johnson & Johnson October 2000 - March 2003
PAREXEL International Corporation January 2000 - August 2000
PAREXEL International Corporation September 1997 - December 1999
PAREXEL International Corporation March 1997 - September 1997
Astra USA, Inc. February 1995 - March 1997
Skills
Clinical Trials, Clinical Development, Clinical Research, Clinical Study Design, Clinical Strategy, Clinical Pharmacology, Pain Management, Acute Pain Management, Chronic Pain, Biotechnology, Neuroscience, Critical Care, Medical Affairs, Regulatory Requirements, Drug Development, Medical Writing, REMS, Medical Education, Outcomes Research, Pharmacovigilance
Education
Massachusetts General Hospital
Residency, Anesthesiology Residency Program
Montefiore Hospital & Medical Center
Residency & Internship, Internal Medicine Residency Program
Mount Sinai School of Medicine of New York University
Doctor of Medicine (M.D.)& PhD
Mount Sinai School of Medicine of New York University
Doctor of Philosophy (Ph.D.), Human/Medical Genetics
PAREXEL International Corporation January 2014 - Present
Merck 2002 - November 2013
Skills
Regulatory Requirements, eCTD, Pharmaceutical Industry, Culture of Compliance, eCTD Assembly & Delivery, FDA Submission Process, Change Agent, Regulatory Strategies, Regulatory Publishing, Risk Mitigation, Risk Identification, Regulatory Filings, Process Optimization, Global Process Alignment, Continuous Improvement, Employee Training, Team Leadership, Maintaining Metrics, Customer Service, Outsourcing Services, Electronic Common..., FDA, CRO, Clinical Development, Drug Development, Validation
Education
Temple University
Master of Science, Quality Assurance & Regulatory Affairs
DeSales University
Master of Business Administration (MBA), Information Systems
Gwynedd-Mercy College
Bachelor of Arts (BA), English
Montgomery County Community College
Associate of Arts (AA), Liberal Studies
Ferreira Dancewear & Costumes, LLC February 2011 - Present
StarQuest International, Inc. January 2010 - May 2010
StarQuest International December 2002 - May 2009
PAREXEL International Corporation September 2000 - July 2002
PAREXEL International Corporation July 1999 - October 2000
PAREXEL International Corporation July 1998 - June 1999
PAREXEL International Corporation September 1997 - June 1998
Skills
PC & Mac Proficient, FileMaker Pro, Outlook, Microsoft Word, Microsoft Excel, PowerPoint
Education
Rhode Island School of Design
Bachelor's Degree, Illustration, College
North Reading High School 1989 — 1993
High School Diploma