U.S. Food and Drug Administration (FDA)
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Customer service: 1 (888) 463-6332 Emergency: 1 (866) 300-4374 Headquarters: Silver Spring, MD Jurisdiction: United States of America Founded: June 30, 1906 Founders: Theodore Roosevelt, Harvey Washington Wiley
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U.S. Food and Drug Administration (FDA) Employees
Cars.com 2015 - Present
Freelance 2011 - 2015
INNOCEAN USA 2014 - 2014
Team One, a Division of Saatchi & Saatchi 2012 - 2014
U.S. Food and Drug Administration (FDA) 2011 - 2012
American Institutes for Research 2008 - 2010
UCSF Medical Center 2006 - 2008
California College of the Arts 2004 - 2006
University of California, San Francisco 2003 - 2004
Skills
Content Strategy, Social Media Marketing, Email Marketing, Mobile Strategy, Web Content, SEO, Strategy, Content Management, Social Marketing, Strategic Communications, Web Content Management, Social Media, Blogging, Digital Strategy, Social Networking, Analytics, KPI Dashboards, Paid Search Strategy, Marketing, Usability, Digital Media, Digital Marketing, Online Marketing, Public Relations, Web Marketing, Web Analytics, Marketing Communications, Facebook, SEM, Advertising, Copywriting, Press Releases, Editing, Google Analytics, PPC, Newsletters, Content Development, New Media, Online Advertising, Management, Marketing Strategy, Integrated Marketing, User Experience, Social Media Measurement
Education
University of California, Berkeley 1999 — 2003
BA, Mass Communication/Media Studies
The Johns Hopkins University 2009 — 2012
MA, Communication and Digital Technologies
Hallmark Automotive February 2013 - Present
Nissan North America August 2012 - February 2013
Alexander Automotive Group July 2010 - September 2012
Harpeth River Watershed Association May 2008 - July 2010
U.S. Food and Drug Administration (FDA) September 2009 - June 2010
Middle Tennessee State University August 2008 - January 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Phone Etiquette, Multi Tasking, Multi-line Phone, Advertising, Employee Training, Environmental Science, Water Quality, Erosion Control, Native Plants, Wildlife Biology, Fishing, Report Writing, Psychology, Management, Customer Satisfaction, Leadership, Marketing Strategy, Negotiation, Public Speaking, Account Management, Customer Service, Sales, Sales Management, Team Building
Education
Martin Methodist College
Bachelor of Science (BS), Biology, General
Middle Tennessee State University
Master's degree, Environmental Biology
Law Offices of Stewart and Stewart 1993 - Present
Law Offices of Stewart and Stewart 1987 - 1993
U.S. Food and Drug Administration (FDA) 1985 - 1986
The Sporicidin Company (Pharmaceutical) 1982 - 1984
Skills
International Trade Law, Corporate Law, Appeals, International Trade, Customs Regulations, Administrative Law, Antidumping, Courts, Civil Litigation, International Law, Countervailing Duty, Litigation, Legal Research
Education
The George Washington University Law School 1984 — 1987
Doctor of Law (J.D.)
American University 1980 — 1984
Bachelor of Arts (B.A.), Economics and Political Science
American University
Minor, Psychology
Navy Federal Credit Union January 2014 - Present
EDC Consulting LLC November 2012 - December 2013
Mythics March 2012 - November 2012
U.S. Food and Drug Administration (FDA) June 2011 - March 2012
Guident Technologies September 2008 - May 2011
Headstrong January 2008 - August 2008
NAID, Inc July 2007 - October 2007
Booz Allen Hamilton December 1996 - July 2007
The MITRE Corporation October 1986 - November 1996
Skills
Program Management, SharePoint, Project Management, PMP, SDLC, Project Portfolio..., Requirements Gathering, Visio, Governance, Requirements Analysis, Risk Management, PMO, Analysis, Software Project..., Enterprise Architecture, Management, Business Process Design, Business Process, IT Strategy, Oracle, Earned Value Management, Integration, Business Analysis, Business Intelligence, Leadership, Information Technology, Data Modeling, ERP, Requirements Management, Agile Methodologies, MS Project, ITIL, CMMI, Process Improvement, Change Management, Management Consulting, Data Warehousing, Project Planning, Software Documentation, IT Management, Vendor Management, Business Process..., Resource Management, Agile Project Management, SOA, Business Requirements, Oracle Applications, Atlassian JIRA, ITIL Certified
Education
Shepherd University 1982 — 1986
B. S, Political Science
Genentech August 2015 - Present
The Dominion Group March 2015 - May 2015
Gilead Sciences, Inc. November 2014 - December 2014
Novant Health Prince William Medical Center September 2014 - October 2014
U.S. Food and Drug Administration (FDA) May 2014 - June 2014
Kmart Pharmacy April 2012 - November 2013
Education
Shenandoah University 2012 — 2015
Master of Business Administration (M.B.A.)
Shenandoah University 2011 — 2015
Doctor of Pharmacy (Pharm.D.)
University of California, San Diego 2007 — 2011
Bachelor of Science (BS), Pharmacological Chemistry
California State University Long Beach August 2007 - Present
U.S. Food and Drug Administration (FDA) March 2003 - August 2007
M.D. Anderson Cancer Center September 1999 - March 2003
Education
State University of New York at Stony Brook
Ph.D., Statistics
Lachman Consultant Services Inc. July 2014 - Present
Lachman Consultant Services Inc. July 2011 - Present
Lachman Consultant Services Inc November 1993 - December 2007
U.S. Food and Drug Administration July 1991 - November 1993
US Food and Drug Administration 1993 - 1993
US Food and Drug Administration January 1991 - July 1991
U.S. Food and Drug Administration February 1988 - January 1991
US Food and Drug Administration August 1980 - February 1988
U.S. Food and Drug Administration (FDA) August 1972 - June 1976
Skills
Biotechnology, GxP, Quality System, Clinical Research, Medical Devices, Laboratory, Supplements, Change Control, Analytical Chemistry, CAPA, Start-ups, Aseptic Processing, CRO, Pharmacovigilance, Biopharmaceuticals, FDA, HPLC, ISO 13485, Testing, Chemistry, Validation, Quality Control, Computer System..., Regulatory Submissions, Regulatory Requirements, GLP, Oncology, Drug Delivery, Lifesciences, Vaccines, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, R&D, V&V, Microbiology, Quality Assurance, GMP, Technology Transfer, Commercialization, GCP, Drug Development, CTMS, Sop, Pharmaceutics, Quality Auditing, Program Management, Manufacturing, Drug Discovery, Clinical Development
Education
Towson University 1969 — 1972
BS, Biological Sciences
LEO Pharma Inc. March 2014 - Present
LEO Pharma December 2011 - February 2014
Royal Embassy of Denmark in Washington, DC February 2011 - December 2011
U.S. Food and Drug Administration (FDA) March 2011 - August 2011
AstraZeneca December 2009 - January 2011
Headquarter at Danish Policy Party 2005 - 2010
Danish Medicines Agency December 2008 - December 2009
SAS (Scandinavian Airlines) 2006 - 2007
Svalen and Steno Pharmacy 2004 - 2005
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Requirements, Regulatory Intelligence, FDA, Public Health Sciences, Stakeholder Management, Market Access, Lobbying, Pharmacetical Marketing..., Health Economics, Change Management, US Healthcare System, Epidemiology, Communication, International Relations, Public Affairs, Health Policy, Government Advocacy, Market Research, Negotiation, Strategic Planning, Analysis, Strategic Communications
Education
University of Copenhagen 2006 — 2011
Cand.Scient.San.Publ./ M.Sc. Public Health
Copenhagen Business School 2010 — 2010
University of Mumbai 2007 — 2007
International Institute for Population Sciences, IIPS
The Royal Danish University of Pharmaceutical Sciences 2004 — 2006
BA Pharm., Pharmaceutical Science
Greve High School 2001 — 2004
Math, Physics, Chemistry, Political Science
U.S. Food and Drug Adminstration (FDA) September 2015 - Present
U.S. Food and Drug Administration (FDA) December 2014 - September 2015
U.S. Food and Drug Administration November 2013 - December 2014
University of Colorado School of Medicine September 2012 - October 2013
University of Colorado School of Medicine August 2006 - September 2012
Alternatives in Science Career Club 2006 - 2012
University of Colorado School of Medicine June 2002 - February 2004
University of Colorado Denver August 2001 - May 2002
Midwest Research Institute September 1999 - July 2001
Skills
HPLC, Structural Analysis, Peptide Synthesis, Molecular Biology, Chemistry, Protein Chemistry, Circular Dichroism, Differential Scanning..., Purification, Protein Purification
Education
University of Colorado School of Medicine 2006 — 2012
Ph.D., Biochemistry
University of Colorado Denver 2001 — 2003
MS, Chemistry
Benedictine College 1995 — 1999
BS, Chemistry
Michels Consulting LLC October 2014 - Present
Michels Consulting LLC June 2004 - October 2014
KMI, a division of PAREXEL International, LLC August 2000 - May 2004
U.S. Food and Drug Administration (FDA) January 1993 - June 2000
U.S. Food and Drug Administration 1982 - 1992
Skills
FDA, Compliance, Regulatory Affairs, Pharmaceutical Industry, GMP, Auditing, Policy, Strategy, Regulatory Requirements, Drug Development, Change Control, Clinical Trials, Quality Control, Regulations, Quality Management, IND, Internal Audit, GxP
Education
Harvard Kennedy School of Government 1981 — 1981
Massachusetts Institute of Technology 1971 — 1972
Systems Analysis
University of California, Berkeley 1959 — 1963
Bachelor of Arts (B.A.), Chemistry
U.S. Food and Drug Administration (FDA) April 2013 - Present
U.S. Social Security Administration (SSA) April 2009 - April 2013
Maryland State Lottery June 2007 - April 2009
City of Alexandria, VA (City Manager's Office) April 2004 - June 2007
Fairfax County Department of Housing and Community Development July 2002 - April 2004
Maryland State Lottery January 2000 - July 2002
Skills
Government, Policy, Microsoft Office, Public Speaking, Customer Service, Training, Community Outreach, Microsoft Excel, Policy Analysis, Public Policy, Graphic Design, Creative Writing, Strategic Planning, Adobe Creative Suite, HTML Scripting, Social Media Measurement, National Capital Region...
Education
Howard Community College 2015 — 2017
Certificate, Web Technology
University of Baltimore 1999 — 2006
Master of Arts (MA), Publication's Design (Graphic Arts)
Towson University 1994 — 1998
Master of Arts (MA), Mass Communication/Media Studies (Public Relations)
Morgan State University 1988 — 1993
Bachelor of Arts (BA), Telecommunications (Radio and Television)
National Institutes of Health November 2013 - Present
Sweet Candy Cafe November 2012 - Present
Sweet Events and Planning (www.SweetEventsandPlanning.com) October 2008 - Present
U.S. Food and Drug Administration (FDA) July 2009 - May 2011
National Institutes of Health October 2005 - February 2009
YouTube Features Sweet Events and Planning March 2009 - 2009
American Sociological Association September 2003 - September 2005
George Washington University 1996 - 2001
Skills
Event Planning, Community Outreach, Non-profits, Public Speaking
Education
University of Phoenix 2009 — 2015
PhD, Management in Organizational Leadership
University of Phoenix 2006 — 2008
MBA, Business Administration
Shaw University 1990 — 1994
BA, Sociology
Weill Cornell Pain Medicine Center August 2014 - Present
North American Neuromodulation Society (NANS) July 2014 - Present
American Society of Regional Anesthesia and Pain Medicine (ASRA) 2010 - Present
Perseus Medical, Inc. September 2007 - Present
Harvard Medical School, Brigham and Women's Hospital July 2013 - July 2014
The Johns Hopkins Hospital June 2009 - June 2013
U.S. Food and Drug Administration (FDA) October 2012 - November 2012
Skills
Biotechnology, Anesthesiology, Critical Care Medicine, Palliative Care, Interventional Pain..., Entrepreneurship, Drug Discovery, Drug Development, Medical Devices, Biologics, Pharmaceutical Industry, Start-up Ventures, Business Strategy, Cross-functional Team..., Translational Medicine, Cancer Genomics, Oncology Clinical..., Acute Pain Management, Oncology
Education
Harvard Medical School 2013 — 2014
Fellowship, Interventional Pain Medicine
Johns Hopkins School of Medicine 2009 — 2013
Residency, Anesthesiology and Critical Care Medicine
Anderson School of Management, University of California at Los Angeles 2002 — 2009
MBA, Healthcare Entrepreneurship
David Geffen School of Medicine, University of California at Los Angeles 2002 — 2009
M.D., Medicine, Letters of Distinction
Nixon Peabody November 2011 - Present
Reed Smith LLP February 2003 - November 2011
U.S. Food and Drug Administration (FDA) May 1993 - February 2003
FDA 1993 - 2003
Attorney General's Office of Maryland September 1990 - February 1993
Skills
Biotechnology, FDA, Pharmaceutical Industry, Medical Devices, Clinical Trials, GMP, Healthcare, Technology Transfer, Lifesciences, Clinical Research, Start-ups, Patents, Healthcare Information..., Litigation, Hospitals, Medicine, Vaccines, Regulatory Affairs, Civil Litigation, Intellectual Property, Cell, Regulatory Requirements, Licensing
Education
University of Maryland School of Law 1986 — 1990
J.D., American Studies and Women's Studies
UMBC 1974 — 1979
Bachelor of Arts (B.A.), American Studies
Institute of Notre Dame 1970 — 1974
HS
U.S. Food and Drug Administration (FDA) June 2015 - Present
Anne Arundel Medical Center November 2010 - June 2015
CVS Caremark Corporation July 2002 - September 2014
CVS Caremark Corporation 2006 - 2008
Kinney Drugs 2000 - 2002
Porter Hospital 2000 - 2002
Skills
Certified Instructor..., Specialized training in..., Experience managing..., CPR and AED certified,..., Healthcare, Clinical, Retail, Medicare Part D, Pharmacists, Anticoagulation, Community Pharmacy
Education
Albany College of Pharmacy and Health Sciences, Union University
B.S., Pharmacy
Shenandoah University
Doctor of Pharmacy
University of Southern Indiana
Certificate in Anticoagulation Management
U.S. Food and Drug Administration (FDA) January 2014 - Present
Center for Strategic and International Studies July 2009 - December 2013
Center for Strategic and International Studies February 2009 - June 2011
Center for Strategic and International Studies June 2007 - January 2009
Center for Strategic and International Studies July 2005 - June 2007
Skills
Policy Analysis, Foreign Policy, International Relations, International..., Public Policy, Research, International Security, Politics, Political Science, Diplomacy, Foreign Affairs, Human Rights, Political Risk Analysis, Economic Development, NGOs, Government, Proposal Writing, Africa, Economics, Grant Writing, Fundraising, Policy
Education
American University 2003 — 2005
MA, International Political Economy/International Economics
Florida State University 1999 — 2002
BA, International Affairs & Spanish
U.S. Food and Drug Administration (FDA) September 2008 - Present
FDA July 2013 - October 2013
Goulston & Storrs September 2005 - July 2008
Greater Boston Legal Services June 2003 - August 2003
U.S. Department of Education July 2000 - July 2002
Education
Harvard Law School 2002 — 2005
Vanderbilt University 1996 — 2000
BA, Anthropology
U.S. Food and Drug Administration (FDA) March 2013 - Present
American Institutes for Research November 2008 - March 2013
Massachusetts General Hospital November 2005 - September 2008
The Communication Group July 2005 - August 2005
Massachusetts House of Representatives May 2001 - October 2004
Skills
Management, Integrated Marketing, Marketing Management, Social Media, Direct Marketing, Trade Shows, Event Planning, Event Management, Public Speaking, Public Relations, Marketing, Marketing Strategy, Project Management, Marketing Communications, Budgets, Advertising, Sponsorship, Media Relations, Strategic Communications
Education
Boston University 2004 — 2005
Masters, Public Relations
Northeastern University 1996 — 2001
B.A., International Affairs
U.S. Food and Drug Administration (FDA) March 2011 - Present
FDA 2009 - February 2011
Skills
Leadership Development, Organizational..., Personal Development, Coaching, Training, Executive Coaching, Community Outreach, Management, Organizational..., Workshop Facilitation, Career Development, Leadership, Emotional Intelligence, Staff Development, Public Speaking, Conflict Resolution
Education
Western Kentucky University 1988 — 1991
BS
Arizona State University
MS, Management of Technology