MCRA Company
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MCRA Employees
The Gladstone Institutes February 2013 - Present
Bayfield Solutions LLC June 2012 - February 2013
MCRA May 2011 - June 2012
MCRA July 2008 - May 2011
United States Patent and Trademark Office (USPTO) May 2007 - May 2008
The Denton Company 2002 - 2007
Shutdown Planner 2000 - 2005
Skills
SQL, Hadoop, Data Science, Data Visualization, PostgreSQL, ETL, Python, Django, Patent Searching, Medical Devices, Biomedical Engineering, JavaScript, Backbone.js, jQuery, CSS, HTML 5, Amazon Web Services..., Git, Github, Vim
Education
Michigan Technological University
Master of Engineering, Biomedical Signal Processing
Michigan Technological University
Bachelor of Science, Biomedical Engineering
Western Michigan University September 2011 - Present
MCRA 1997 - Present
Eastern Michigan University September 1991 - August 2002
Skills
Psychotherapy, Counseling, Treatment, Higher Education, Student Services, Group Therapy, Teaching, Program Development, Mental Health, Volunteer Management, Student Affairs, Social Services, Psychology, Public Speaking, Conflict Resolution, Community Outreach, Clinical Supervision
Education
Nova Southeastern University 1983 — 1992
Psy.D., Clincial Psychology
Macalester College 1977 — 1981
Bachelor of Science, Psychology
MCRA January 2014 - Present
Medical University of South Carolina July 2013 - January 2014
Clemson University January 2013 - May 2013
Clemson University Creative Inquiry August 2012 - May 2013
Clemson University November 2010 - May 2013
Skills
Regulatory Affairs, Scientific Writing, FDA, Tissue Engineering, Cell Culture, Nanoparticles, Experimentation, Fluorescence Microscopy, Research, Biomedical Engineering, Microscopy, Biomaterials, Cell, Bioengineering, Science, Nanomedicine, Travel, Solidworks, Polymers, Confocal Microscopy, Journalism, Tutoring, Team Leadership, Mentoring, Medical Devices
Education
Clemson University 2009 — 2013
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Nanyang Technological University 2012 — 2012
MCRA January 2015 - Present
inVentiv Health Clinical June 2014 - December 2014
Brainscope Company Inc. January 2012 - October 2013
IMC Inc. October 2010 - December 2011
International Partnership for Microbicides January 2006 - October 2010
Skills
Clinical Research, Biotechnology, Clinical Data Management, Sop, Clinical Trials, Computer System..., CRO, MS Project, SharePoint, Livelink, Medical Devices, Research, ArcGIS, GAMP, Product Development, Medical Device R&D, Product Management, CRA certification, ICH/GCP certification, MS Office Suite, Adobe Photoshop, Adobe PageMaker, Clinical Drug Safety..., Site Management, GPP, Clinical Monitoring, NIH, Vaccines, Clinical Development, GCP, FDA, Protocol, Quality Assurance, 21 CFR Part 11
Education
Georgetown University 2008 — 2010
MS
Stanford University 2000 — 2005
BS
Karachi Grammar School 1984 — 2000
A' Levels
East Point Systems, Inc. December 2014 - Present
Jackson Hewitt Tax Service Inc. December 2011 - February 2014
MCRA November 2012 - May 2013
Boston University School of Medicine June 2007 - August 2008
Saint Francis Hospital June 2005 - September 2006
Drexel University College of Medicine September 2000 - June 2004
Skills
Biomedical Engineering, Data Analysis, Medical Devices, Salesforce.com, Neuroscience, Neurophysiology, Lifesciences, Microsoft Excel, Healthcare, Troubleshooting, EEG, IRS Enrolled Agent, Medical Device R&D, Biotechnology, Clinical Research, Biomechanics, Clinical Trials
Education
Drexel University
Master of Science (M.S.), Biomedical Engineering
Tufts University
Bachelor of Science (BS), Biology, Biomedical Engineering Systems
PRA Health Sciences October 2015 - Present
Parexel July 2012 - October 2015
MCRA November 2008 - 2011
Carticept Medical, Inc. 2005 - 2007
Clinical Research 1996 - 2004
Education
Gardner-Webb University
MCRA May 2014 - Present
MCRA April 2011 - May 2014
Evaheart Medical USA July 2007 - April 2011
rms Company 2004 - 2007
Cardiac Science 2001 - 2004
Sanmina-SCI 1998 - 2001
Sanmina-SCI 1995 - 1998
Carrier Corporation 1986 - 1994
Skills
Medical Devices, Quality System, FDA, Manufacturing, Regulatory Affairs, Design Control, Engineering, ISO 13485, CAPA, ISO, Validation, V&V, ISO 14971, Operational Excellence, Biomedical Engineering, Supplier Quality, 21 CFR Part 11, Quality Auditing, Change Control, FDA GMP, DMAIC, Regulatory Submissions, Quality Assurance
Education
Purdue University 1982 — 1986
BS, Electrical Engineering
United Electronics Institute 1971 — 1973
BSI
Lead Auditor Training
Johnson & Johnson May 2013 - Present
Johnson & Johnson January 2011 - Present
MCRA October 2004 - January 2011
Florida Department of Law Enforcement November 2002 - October 2004
Gainesville Police Department September 1997 - October 2004
Skills
Healthcare Compliance, Compliance, Medical Devices, Health Care Compliance, Policy, Regulatory Affairs, Clinical Research, FDA, Ethics, Healthcare, Privacy Law, Governance, Pharmaceutical Industry, HIPAA, Regulations, Licensing
Education
New York Law School
J.D., Law
Saint Leo University
B.A., Criminal Justice and Law
RTI Surgical October 2013 - Present
US Navy Reserve May 2014 - Present
Massachusetts Air National Guard September 2009 - June 2014
Somers Fire Department August 2005 - March 2014
MCRA March 2011 - October 2013
Baystate Health August 2005 - March 2011
Ernst & Young May 2001 - October 2003
Oxford HealthCare 1995 - 1998
Skills
Business Ethics, Compliance, Healthcare, Military, Firefighting, Leadership, Medical Devices, Pharmaceutical Industry, FCPA, UK Bribery Act, Healthcare Consulting, Healthcare Management, HIPAA, Anti-corruption, Medical Compliance, Strategy, Training, Risk Assessment
Education
Rice University 1998 — 2000
Masters in Business Administration, Business
University of New Hampshire 1992 — 1995
BA, Political Science
Seton Hall Law School 2011 — 2011
Certificate, Graduate Certificate in Pharmaceutical and Medical Device Law & Compliance
MCRA April 2013 - Present
MCRA March 2010 - April 2013
SpinalMotion, Inc. August 2008 - February 2010
Capital Clinical Research Associates March 2007 - July 2008
Capital Clinical Research Associates September 2005 - March 2007
Skills
Clinical Research
Education
American University 2001 — 2005
BA, Psychology
Global Pacific Manufacturing Group LLC 2010 - Present
MCRA 2008 - 2010
Medu-Scientific 2007 - 2008
ConMed Endoscopic Technologies 2004 - 2007
MedSource Technologies 2002 - 2004
Thoratec 2000 - 2002
MacNeill Engineering 1997 - 2000
Dolan Industries 1995 - 1997
Alden Research Laboratory 1992 - 1995
Education
University of Massachusetts Lowell
Moley Marketing LLC January 2011 - Present
Centinel Spine October 2014 - Present
MCRA June 2015 - Present
Misonix September 2014 - Present
TransCorp Spine June 2011 - December 2014
Baxano Surgical December 2011 - June 2014
ORTHOCON November 2009 - January 2011
Stryker Spine August 2006 - November 2009
Ethicon (Johnson & Johnson) February 2002 - August 2006
MARKETSOURCE May 1999 - January 2002
Skills
Medical Devices, Market Development, Marketing Strategy, Market Planning, Segmentation, Promotions, Competitive Intelligence, Product Management, Medical Device Product..., Medical Device Product..., Commercialization, New Product Release, New Media Product..., Introducing New Products, New Product Ideas, Spine, Product Launch, Competitive Analysis, Marketing, Management, Strategy, Capital Equipment, Surgeons, Orthopedic, Product Marketing, Sales Operations, Global Marketing, Cross-functional Team..., Business Development, Start-ups, Lead Generation, Product Development, Marketing Research, Business Planning, Marketing Communications, Selling, New Business Development, Advertising, Positioning, Pricing, Leadership, Market Research, B2B, Entrepreneurship, Trade Shows, Market Analysis, Sales, Sales Presentations, Operating Room, Strategic Partnerships
Education
Rutgers University-New Brunswick
MBA, Marketing
Northeastern University
BS, Journalism/Advertising/Business
Kinnelon High School
Cambridge Associates November 2012 - Present
MCRA April 2010 - September 2012
Certified Financial Planners Board of Standards, Inc. April 2006 - June 2008
Skills
Medical Devices, FDA, Clinical Research, Regulatory Affairs, Clinical Trials, Healthcare, Orthopedic, Research, Health Insurance, Public Policy, Data Analysis, Strategic Planning, Policy Analysis, Nonprofits, Business Strategy, Training
Education
University of the District of Columbia 2011 — 2012
Bachelor of Arts (B.A.), Political Science and Government
Colorado State University-Pueblo 2000 — 2005
Bachelor of Science (BS), Business Administration and Management, General
MCRA August 2011 - Present
Brower Piven March 2011 - July 2011
The Law Office of Donna Wulkan January 2010 - October 2010
Skills
Medical Devices, FDA, Regulatory Affairs, Clinical Trials, Healthcare, Clinical Research, Hospitals, Due Diligence, Data Analysis, Research, Strategic Planning, Orthopedic, Spine, Project Management
Education
American University, Washington College of Law 2007 — 2010
JD, Law
Boston University 2002 — 2005
BA, Psychology, English
PAREXEL May 2015 - Present
PAREXEL March 2014 - May 2015
CR Bard September 2013 - December 2013
VertiFlex, Inc. September 2011 - August 2013
MCRA March 2008 - September 2011
US Oncology April 2007 - March 2008
Silimed, Inc January 2007 - April 2007
Texas Workforce Commission October 2005 - December 2006
Pitman Creek Physical Therapy October 1999 - January 2004
Skills
Budgets, Process Scheduler, Research, Data Collection, Workshop Facilitation, Clinical Monitoring, Medical Devices, Public Speaking, Health Insurance, Spine, Surgeons, Patient Recruitment, Site Selections, Travel, Travel Planning, Continuing Education, Clinical Research, Clinical Trials, Clinical Data Management, Spinal Stenosis, Orthopedic, Social Services, Sociology, Adult Education, Oral & Written..., Written & Oral..., Report Writing, Leisure Travel, Regulatory Affairs, Regulatory Submissions, Healthcare, Surgery, Physician Relations, FDA, EMR, EHR, GCP, CTMS, IRB, Protocol, Medical Research, Regulatory Documentation, CRO, Clinical Study Design, Sop, Cardiology, ISO 13485, Neurosurgery, CAPA, Vascular
Education
The University of Texas at Dallas 2002 — 2005
Bachelor of Arts, Sociology
Collin County Community College 1999 — 2002
Associate's degree, Sociology
Merrick Ventures, LLC July 2010 - December 2010
Astellas Pharma June 2010 - August 2010
Centinel Spine, Inc. March 2008 - June 2009
MCRA July 2006 - March 2008
Wesleyan University, Center for the Arts September 2002 - May 2006
Skills
Due Diligence, Venture Capital, Entrepreneurship, Start-ups, Product Development, Private Equity, Healthcare, Corporate Development, Valuation, Press Releases, Analysis, Medical Devices, Healthcare Information...
Education
The University of Chicago - Booth School of Business 2009 — 2011
Master of Business Administration, Entrepreneurship, Strategic Management, Finance
Wesleyan University 2002 — 2006
Bachelor of Arts, College of Social Studies
FactSet April 2008 - Present
MCRA August 2007 - April 2008
Skills
Research, Financial Modeling, Monte Carlo Simulation, Options, Option Pricing Models, Derivatives, Portfolio Performance..., Portfolio Management, Asset Allocation, Real Estate, International Real..., Fixed Income Analysis, Fixed Income Strategies, Econometrics, Regression Analysis, Financial Statement..., Equity Capital Markets, VBA
Education
New York Institute of Technology-Old Westbury
St. Jude Medical February 2015 - Present
St. Jude Medical June 2012 - Present
MCRA March 2011 - June 2012
MCRA April 2009 - March 2011
MCRA March 2008 - April 2009
MCRA September 2007 - March 2008
Lawline.com January 2006 - May 2007
Spinal Concepts 2003 - 2004
Skills
IDE Reimbursement..., Payor Advocacy,..., Clinical Literature..., Clinical Trials, Study Design, Commercialization, Business Strategy, Clinical Research, Protocol Development, Clinical Trial..., Health Economics, Strategic Planning, Protocol, FDA, Medical Devices, Orthopedic, Lifesciences, Medicare, Biotechnology, Clinical Study Design, Reimbursement, Start-ups, Cardiology
Education
New York Law School 2004 — 2007
Juris Doctor, Law
Southern Methodist University Dedman School of Law 2006 — 2006
J.D., Food and Drug Law (Visiting)
The University of Texas at Austin 2000 — 2004
Bachelor of Science, Corporate Communication
Eastern Virginia Medical School August 2013 - Present
MCRA June 2010 - June 2013
Johns Hopkins University August 2007 - May 2010
Johns Hopkins University May 2008 - May 2009
Memorial Sloan-Kettering Cancer Center August 2007 - August 2007
Sanofi-Aventis May 2007 - August 2007
Harlan Sprague-Dawley June 2006 - August 2006
Skills
Cell Culture, Western Blotting, Tissue Engineering, Stem Cells, Biomedical Engineering, Biotechnology, Medical Devices, Lifesciences, Gel Electrophoresis, Clinical Trials, Clinical Research, Biomaterials, Molecular Biology, Statistics, Research, Cell Biology, Matlab, Regulatory Affairs, FDA, PCR
Education
Eastern Virginia Medical School 2013 — 2017
Doctor of Medicine (MD)
The Johns Hopkins University 2006 — 2010
Bachelor of Science
Hunterdon Central Regional HS 2002 — 2006
MCRA November 2012 - Present
Philips Remove Cardiac Services February 2011 - November 2012
Strategic Employees Benefits Services January 2007 - April 2008
Skills
Outlook, SQL, VMware, Networking, Insurance, Team Building, Customer Service
Education
Sacred Heart University 1971 — 1975
BA, Education