Experience
Alcon Laboratories, Inc.   September 2007 - August 2014
Regulatory Affairs Professionals Society (RAPS)   2014 - 2014
Alcon, a Novartis company  2004 - 2007
BioCure Corporation   February 2004 - September 2004
Ciba Vision Corporation  April 2003 - February 2004
Georgia Institute of Technology  1996 - 2002
Georgia Institute of Technology  1995 - 2002

Skills
R&D, Chemistry, Design of Experiments, UV/Vis, Formulation, FDA, Validation, Analytical Chemistry, Technology Transfer, Chromatography, IR spectroscopy, Interpersonal..., HPLC, Characterization, GMP, GLP, Fluent in both English,..., Strong verbal and..., SOP, Interpersonal..., Knowledge of GLP’s..., NMR, UV-vis and IR..., DSC & TGA thermal..., Project Management, IR Spectroscopy, Medical Devices

Education
Georgia Institute of Technology   1998 — 2004
PhD, Polymer Chemistry

Georgia Institute of Technology   1995 — 1998
MS., Organic Chemistry

University of Central Florida   1991 — 1995
B.S., Chemistry

Experience
http://www.RegulatoryDoctor.US   October 2011 - Present
FDAnews  October 2014 - Present
Regulatory Affairs Professionals Society (RAPS)   July 2014 - Present
Global Compliance Seminar   October 2011 - Present
GLG - Gerson Lehrman Group  February 2013 - Present
Audio Educator   August 2013 - Present
Compliance Trainings   August 2013 - Present
OnlineCompliancePanel   August 2012 - Present
Signet Medical Systems, Inc.   June 2012 - Present
Compliance2Go   February 2012 - Present

Skills
FDA, Regulatory Affairs, Medical Devices, Clinical Trials, ISO 13485, GMP, CAPA, Quality System, Pharmaceutical Industry, Regulatory Submissions, Regulatory Requirements, Drug Development, Quality Assurance, Design Control, GLP, Business Strategy, Management Consulting, GCP, Quality Auditing, ISO 14971, Quality Management, PMA, 21 CFR, CE marking, Risk Management, FDA GMP, Strategic Consulting, Medical Device Directive, Auditing, Internal Audit, FMEA, Business Coaching, Molecular Diagnostics, Class III Medical..., Combination Products, Regulatory Filings, Drug Safety, Regulatory Documentation, Biocompatibility, Medical Device R&D, Medical Compliance, CMDCAS, Drug Eluting Stents, IVDD, MDR, Problem Solving, ISO 9001, CMDR, CLIA, Sop

Education
Taft Law School   2007 — 2011
Exe JD candidate

The Johns Hopkins University   2008 — 2009
N/A Class

Regulatory Affairs Professional Society   2007 — 2007
RAC

University of California, San Diego   2007 — 2007
Certificate

University of Missouri-Columbia   1991 — 1993
Ph.D.

Experience
Regulatory Affairs Professionals Society (RAPS)   January 2010 - Present

Skills
Strategic Planning, Healthcare, Business Development, Project Management, Business Strategy, Program Management, Marketing Strategy, Budgets, Marketing Communications, Strategy, Nonprofits, Leadership, Market Research, Marketing, Product Development, Pharmaceutical Industry

Education
University of Maryland - Robert H. Smith School of Business   2006 — 2009
MBA

Experience
Association for the Advancement of Medical Instrumentation  March 2014 - Present
HDMA - Healthcare Distribution Management Association  December 2005 - February 2014
American Pharmacists Association  July 2003 - December 2005
Professional Education Services Group  December 2002 - May 2003
Academy of Managed Care Pharmacy  April 2001 - October 2002
Regulatory Affairs Professionals Society (RAPS)   May 1998 - April 2001
Water Environment Research Foundation  1997 - 1998

Skills
Program Development, Program Administration, Continuing Education, Event Planning, Writing, Healthcare, Strategic Planning, Public Speaking, Teaching, Event Management, Project Management, Marketing, Management, Pharmaceutical Industry

Education
George Mason University   1993 — 1999
BS, Health, Fitness & Recreation Resources

Experience
FDA  December 2012 - Present
Woodrow Wilson International Center for Scholars  September 2011 - December 2012
Regulatory Affairs Professionals Society (RAPS)   2012 - 2012
Circuit Court for Worcester County   February 2006 - February 2007
Financial Industry Regulatory Authority  October 2005 - February 2006
Dreschler Larkin & Walters LLP   October 2004 - October 2005
U.S. District Court District of Columbia   January 2005 - June 2005
Office of Counsel to Inspector General, HHS   June 2004 - August 2004
K&L Gates  June 2003 - August 2003
Human Genome Sciences  February 2001 - July 2002

Skills
Rule Of Law, Legal Research and..., Policy Analysis, FDA Regulations, Regulatory Affairs, FDA, Writing, ELISA, GMP, Clinical Development, Budgets, Data Analysis, Intellectual Property, Criminal Law, Biotechnology, Public Policy, Policy, Lifesciences, Legal Writing, Statistics, Litigation, Product Development, Government, Cell Culture, Legal Research, Nonprofits, Administrative Law, Courts, Synthetic Biology, Research, Biopharmaceuticals, International Relations, Medical Devices, Molecular Biology, Grant Writing, Science, Patents, Life Sciences

Education
The Johns Hopkins University   2010 — 2012
MS, Bioscience Regulatory Affairs

Widener University School of Law (PA)   2002 — 2005
Juris Doctorate, Law, Concentration in Intellectual Property Law

University of Maryland College Park   1998 — 2002
Bachelors, Cell Biology and Molecular Genetics

Experience
Regulatory Affairs Professionals Society (RAPS)   April 2012 - December 2013
Regulatory Affairs Professionals Society (RAPS)   July 2010 - April 2012
National Institutes of Health  May 2010 - July 2010
The University of Tampa  August 2008 - May 2010

Skills
Marketing, Business Development, Microsoft Office, Event Planning, Marketing Strategy, Account Management, Event Management, Project Management, Program Management, Training, Online Marketing, Leadership, Email Marketing

Education
Montgomery College   2013 — 2015
Nursing

University of Tampa - John H. Sykes College of Business   2006 — 2010
Bachelors of Science, Marketing

Experience
Regulatory Affairs Professionals Society (RAPS)   April 2013 - March 2015
Children's Medical Center Dallas  May 2007 - June 2011
UT Southwestern Medical Center  October 2004 - September 2005
FDC Reports (now Informa)   October 1984 - September 2004

Skills
Editing, Copy Editing, Web Content, Strategic Communications, Newsletters, Publications, Public Affairs, AP Style, Blogging, Facebook, Press Releases, Editorial, Management, Social Networking, Marketing Communications, Content Strategy, Media Relations, Brand Management, Internal Communications, Training, Technical Writing, Magazines, Nonprofits, Healthcare, Creative Writing, Content Management, Corporate Communications, Research, Copywriting, Social Media Marketing, Creative Direction, Public Relations, Advertising, Integrated Marketing, Interviews, Content Development, Journalism, Feature Articles

Education
Swarthmore College
BA, History, Political Science, Art History

Experience
Harford Community College  2004 - Present
MA & PA Heritage Trail   October 2002 - Present
Regulatory Affairs Professionals Society (RAPS)   February 2004 - June 2004
Rite Aid  April 2000 - February 2004
Ajilon Consulting  1999 - 2000
London Fog  1990 - 1994

Skills
Training & Development, Public Speaker, Group Presentations, Event Management, Conferences, Coordination, Strategic Planning, Writing, Public Relations, Staff Development, Team Building, Non-profits, Event Planning, Organizational..., Public Speaking, Employee Training, Leadership, Teaching, Leadership Development, Project Planning, Nonprofits, Customer Service, Teamwork, Career Counseling, Program Development, Community Outreach, Management, Recruiting, Time Management, Social Networking, Human Resources, Program Management, Interviews, Change Management, Supervisory Skills, Fundraising, Training, Curriculum Design, Employee Benefits, Higher Education, Workshop Facilitation, Administration, Volunteer Management, Resume Writing, Grant Writing, Policy, Instructional Design, Government, Proposal Writing, Executive Coaching

Education
Harford Leadership Academy   2008 — 2008

The Johns Hopkins University - Carey Business School   1991 — 1994
MS, Organizational Development

Towson University
BS, Business Administration

Experience
DRW Research & Information Services, LLC   June 2006 - Present
Regulatory Affairs Professionals Society (RAPS)   March 1999 - June 2006
The Gillette Company  September 1991 - March 1999
R..O.W. Sciences   September 1990 - August 1991
Labat Anderson Inc./US Environmental Protection Agency - Office of Toxic Substances Chemical Library   March 1989 - September 1990

Skills
Research, Healthcare, Writing, Editing, Indexing, Regulatory Affairs, Corporate Communications, Online Community...

Education
University of Maryland College Park   1987 — 1988
MLS, Library Science

Vassar College   1981 — 1985

Experience
PwC  July 2015 - Present
Regulatory Affairs Professionals Society (RAPS)   April 2015 - July 2015
Regulatory Affairs Professionals Society (RAPS)   March 2014 - March 2015
Regulatory Affairs Professionals Society (RAPS)   December 2011 - March 2014
Regulatory Affairs Professionals Society (RAPS)   November 2010 - December 2011
New England States Consortium Systems Organization   July 2010 - August 2010
Rhode Island Executive Office of Health and Human Services   June 2009 - May 2010

Skills
Public Health Policy, Regulatory Affairs, Health Policy, Medical Devices, Biotechnology, Healthcare, Pharmaceutical Industry, FDA, Writing, Government, Lifesciences, Policy, Strategy, Strategic Communications, Research, Clinical Trials, Regulations, Editing, Regulatory Requirements, Corporate Communications, Analysis, Data Analysis, Technical Writing, Copy Editing, Medical Writing, GMP, Quality Assurance, Public Health

Education
Providence College   2006 — 2010
BA, Political Science

Experience
Triowave Technologies   2015 - Present
Lir   2015 - Present
Elexes   2014 - Present
Regulatory Affairs Professionals Society (RAPS)   2011 - Present
Intuitive Surgical  2014 - 2014
Home Dialysis Plus, Limited  2013 - 2014
Stryker  2012 - 2013
Medical Device, Biologics and Drugs companies   2009 - 2012
Kriger Research Group International  2009 - 2009
University of Illinois at Chicago  2007 - 2009

Skills
Compliance, Regulatory Affairs, Medical Devices, Risk Management, 510 K, Design Control, PMA, FDA, GMP, Quality Assurance, Regulatory Submissions, Sop, Validation, Quality System, GCP, Clinical Trials, GLP, Software Documentation, SOP, Biotechnology, Pharmaceutical Industry

Education
University of Illinois at Chicago   2007 — 2009
MS, Bioengineering

S.G.S.I.T.S Indore   2003 — 2007
B.E, Biomedical Engineering

Stanford University   2014 — 2014
Project Management

Experience
American Society for Parenteral & Enteral Nutrition (A.S.P.E.N.)   December 2014 - Present
Society for Neuroscience  December 2013 - December 2014
IFMA  January 2012 - November 2013
Regulatory Affairs Professionals Society (RAPS)   November 2010 - December 2011
AIChE  July 2007 - November 2010
Waxman Youth House   September 2001 - April 2007

Skills
Volunteer Development, Strategic Planning, Membership Management, Leadership Development, Budgeting, Community Outreach, Team Building, Non-profits, Professional..., Management, Budgets, Strategy, Fundraising, Volunteering, Leadership, Nonprofits, Project Management, Program Management, Marketing, Social Networking, Recruiting, Proposal Writing, Customer Service, Contract Negotiation, Training, Project Planning, Corporate Communications, Volunteer Management, Staff Development, Event Planning, Negotiation, Executive Management, Public Speaking, Team Leadership

Education
Davidson School of Education   2003 — 2006
M.A., Education

Columbia University in the City of New York   1996 — 2000
B.A., Sociology

List College   1996 — 2000
B.A., Bible

Experience
ASHP  November 2012 - Present
Regulatory Affairs Professionals Society (RAPS)   August 2006 - November 2012
Institute for Professional and Executive Development, Inc.   April 2006 - August 2006
Electronic Retailing Association  February 2005 - March 2006
Tenacity Group  June 2002 - February 2005

Skills
Relationship-building..., Knowledge of..., Training and development, Vendor Management, Microsoft Office, Virtual Events, Growing and developing..., Membership Development, Marketing Strategy, Social Media Marketing, Long-term Customer..., Business Development, Integrated Marketing, Management, Recruiting, Strategic Planning, Strategy, Training, Project Management

Education
University of Maryland College Park   1998 — 2002
Bachelors of Science, Marketing

Experience
The American Speech-Language-Hearing Association (ASHA)   May 2013 - Present
Regulatory Affairs Professionals Society (RAPS)   October 2009 - May 2013
Beamish and Crawford   April 2006 - December 2008
Reckitt Benckiser  July 2005 - April 2006

Skills
Online Marketing, Digital Marketing, Direct Marketing, Marketing Strategy, Online Advertising, Marketing, Market Research, Advertising, Brand Management, Public Relations, Social Media, SEM, Social Networking, Management, PPC, Event Planning, Trade Shows, Social Media Marketing, Google Analytics, Direct Mail, Email Marketing, Marketing Communications

Education
University College Dublin   2004 — 2005
Master of Business Studies, Marketing

University College Dublin   2000 — 2003
Bachelor of Commerce, Business and Marketing

St Josephs CBS/Tenure NS   1985 — 1993

Experience
Regulatory Affairs Professional Society   March 2007 - Present
Regulatory Affairs Professionals Society (RAPS)   2007 - Present
Savoie Media   August 2005 - Present
Regulatory Affairs Professionals Society   2007 - 2011
Discovery Education  2006 - 2007
National Assn of Broadcasters   November 1996 - August 2006

Skills
Video Production, E-Learning, Writing, Strategic Planning, Project Management, Video Editing, Learning Management..., Instructional Design, Non-profits, Producing, Nonprofits, Non-linear Editing, Marketing, Social Media, Content Management, Blogging, Leadership Development, Multimedia, Social Media Marketing, Media Relations

Education
American University   2003 — 2005
Master of Arts, Producing Film and Video

The George Washington University   1992 — 1996
B.A., Radio/Television

Experience
Regulatory Affairs Professionals Society (RAPS)   January 2010 - April 2011
Regulatory Affairs Professionals Society (RAPS)   August 2009 - February 2010
Regulatory Affairs Professionals Society (RAPS)   June 2009 - August 2009
Parenteral Drug Association  October 2008 - April 2009
Parenteral Drug Association  November 2006 - October 2008
Parenteral Drug Association  May 2006 - October 2006
Parenteral Drug Association  October 2005 - May 2006
Association for Financial Professionals  October 2003 - October 2005
Association for Financial Professionals  June 2002 - June 2003
Association for Financial Professionals  August 2002 - May 2003

Skills
Editing, Event Planning, Public Relations

Education
Franklin & Marshall College   1997 — 2001
Bachelor of Arts, English

Experience
Transition Management Consulting, Inc.   February 2005 - Present
Council of Better Business Bureaus  November 2012 - November 2013
Regulatory Affairs Professionals Society (RAPS)   April 2011 - December 2011
Pharmacy Technician Certification Board  January 2009 - June 2010
National Recreation and Park Association  2008 - 2008
Marine Technology Society  2007 - 2008
American Nurses Credentialing Center  2006 - 2006
Community Associations Institute  March 1999 - February 2000
American Association of Museums  1991 - 1999
American Chemical Society  1980 - 1982

Skills
Non-profits, Association Management, Board Development, Fundraising, Non-profit..., Leadership Development, Strategic Planning, Volunteer Management, Program Development, Healthcare, Grants, Coalitions, Program Management, Organizational Needs..., Public Speaking, Budgets, Board Relations, Philanthropy, Event Management, Event Planning, Nonprofits, Human Resources, Leadership, Marketing, Organizational..., Recruiting

Education
University of Maryland - Robert H. Smith School of Business   1978 — 1980
MBA, Organization Behavior and Marketing

University at Albany, SUNY   1972 — 1973
MS, Counseling & Student Personnel Admin.

University at Albany, SUNY   1968 — 1972
BA, Anthropology and Marketing

Lakeland HS   1964 — 1968

Experience
The Wills Group, Inc  January 2014 - Present
SSP America  January 2011 - January 2014
SSP America  2009 - 2011
SSP America  2007 - 2009
SSP America  2005 - 2007
Regulatory Affairs Professionals Society (RAPS)   2003 - 2004
ASAE: The Center for Association Leadership  August 2002 - September 2003
Citi  1999 - 2002

Skills
Brand Development, Integrated Marketing, Brand Management, Marketing Strategy, Creative Direction, Public Relations, Marketing, Retail, Food & Beverage, Restaurants, Hospitality, Marketing Research, Leadership, Internal Communications, Business Development, Marketing Management, Marketing Communications, Advertising, Social Media Marketing, Event Management, Project Planning, Social Networking, Budgets, Event Planning, Social Media, Food, Corporate Communications, Direct Marketing, Strategic Communications, Strategy, Media Relations, New Business Development, Management, Copywriting, Sponsorship, Strategic Planning, Business Strategy, Franchising, Team Building

Education
University of Maryland College Park   1999 — 2003
BS, Marketing

University of Maryland College Park   1999 — 2003
BS, International Business

University of Havana - Havana, Cuba   2002 — 2002
Certificate, Contemporary Cuban Culture and Society

International Institute of Madrid   2001 — 2001
Certificate, Spanish Art, Language and Civilization

Experience
MSA Regulatory Services~   September 2014 - Present
Regulatory Affairs Professionals Society (RAPS)   2002 - 2015
Drug Information Association  2000 - 2015
Auxilium Pharmaceuticals  May 2009 - September 2014
Saint Joseph's University  2013 - 2013
Shire Pharmaceuticals  July 2004 - May 2009
Sanofi-Aventis  2003 - 2004
AstraZeneca  2000 - 2003
Astra Merck / Astra Pharmaceuticals   1995 - 2000
Centocor  1992 - 1995

Skills
Regulatory Strategy, Regulatory Affairs, Pharmaceuticals, Biopharmaceuticals, Regulatory Policy and..., Pharmaceutical Industry, FDA, Clinical Development, Drug Development, Biotechnology, IND, GCP, Vaccines, Strategy, Medical Devices, Therapeutic Areas, Clinical Trials, Biologics, GLP, Commercialization, Regulatory Submissions, Dermatology, eCTD, CRO

Education
The Johns Hopkins University   2014 — 2016
Master's Degree, Regulatory Science (est. completion 2016)

Juniata College   1980 — 1984
B.S., Biology

Experience
HeartWare Inc  June 2011 - Present
Regulatory Affairs Professionals Society (RAPS)   2010 - 2015
Regis College  2002 - 2014
Genzyme  March 1999 - March 2011
Dornier MedTech  1990 - 1993

Skills
Medical Devices, Biotechnology, Personalized Medicine, Regulatory Affairs, Diagnostics, Life Sciences, Microbiology, Biomedical Engineering, Biochemistry, Clinical Trials, GMP, CAPA, ISO 13485, Clinical Research, cGMP, GCP, Quality Systems, FDA, Lifesciences, Hardware Diagnostics, Quality Auditing, Quality System, Quality Assurance, Regulatory Submissions, Validation, Oncology, Biopharmaceuticals, Sop, Design Control, Clinical Development, Technology Transfer, Change Control, Pharmaceutical Industry, Laboratory, GLP, R&D, V&V, Infectious Diseases, Immunology, Commercialization, CTMS, Assay Development, SOP

Education
Quinnipiac University   1973 — 1975
M.H. Sc, Public Health and Epidemiology/Medical Laboratory Sciences

University of Connecticut   1968 — 1972
B. A., Microbiology/Biochemistry

Experience
Nanotherapeutics, Inc.   July 2013 - Present
Exactech  2013 - 2013
American Association of Tissue Banks  2007 - 2013
Regulatory Affairs Professionals Society (RAPS)   2005 - 2013
Regulatory Affairs Professionals Society (RAPS)   2002 - 2013
RTI Biologics, Inc.   2000 - 2012
University of Florida  1995 - 2000
Cordis  1995 - 1996
Ethicon Endo-Surgery  1992 - 1993

Skills
Design Control, ISO 13485, FDA, Medical Devices, Regulatory Affairs, Quality System, Biomedical Engineering, Research, Biologics, Biomaterials, Product Development, Commercialization, Orthopedic, Clinical Development, Pharmaceutical Industry, Quality Auditing, Biotechnology, Lifesciences, ISO 14971, Medical Device Directive, Acquisition Integration, 510(k), IDE, Auditing, Canadian Medical Devices, CE marking, Sports Medicine, Team Management, Department Budgeting, Performance Management, Mentoring Of Staff, Tissue Engineering, Dental Implants, Spinal Implants, Combination Products, Hernia Repair, Clinical Trials, R&D, Life Sciences, V, Orthopedics, R

Education
University of Florida   1994 — 1998
Master of Science (MS), Materials Science and Engineering, 3.85

Ohio University   1989 — 1994
Bachelor of Science (BS), Mechanical Engineering, 3.1

Experience
American Nurses Association  September 2012 - Present
Regulatory Affairs Professionals Society (RAPS)   January 2010 - July 2012
Greater District Heights Community Conversations   2010 - 2011
...and company   August 2005 - January 2010
Union Mortgage Group  2010 - 2010
Comcast  1999 - 2003

Skills
Customer Service, Program Management, Social Media, Nonprofits, Project Management, Research, Public Speaking, Community Outreach, Strategic Planning, Data Analysis, Team Building, Training, Leadership Development, Management, Marketing

Education
August Martin High School
Diploma

Howard University
BS, Computer Science

Experience
Regulatory Affairs Professionals Society (RAPS)   July 2015 - Present

Skills
Customer Service, Team Building, Marketing Communications, Marketing, Microsoft Office, Staff Development, Management, Marketing Management, Teamwork, Event Management, Program Management, Project Planning, Training, Organizational..., Social Media, Coaching, Accreditation, Strategy

Education
University of Liverpool   2010 — 2013
M.Sc. Global Marketing, Marketing, Business

University of Kent   1997 — 2001
BA, American Literature

University of South Carolina-Columbia   1999 — 2000

ICHS

Experience
Regulatory Affairs Professionals Society (RAPS)   October 2014 - Present
ASNR   September 2003 - Present
Board of Regents of the University System of Georgia  2002 - 2003
State Development & Reform Commission   1997 - 2000

Skills
Instructional Design, SQL Server Management..., Business Intelligence, Data Analysis, Adobe eLearning Suite, mLearning, Microsoft Office, CME, Process Improvement, Customer Service, Dreamweaver, E-Learning, Adobe Acrobat, Cross-functional Team..., Training, Analysis, Program Management

Education
The University of Georgia
Master's Degree, Management Information Systems, General

The University of Georgia
Master's Degree, M.Ed. - Instructional Technology

Experience
Department of Health & Mental Hygiene, Office of Health Care Quality   February 2015 - Present
Department of Health & Mental Hygiene, Office of Health Care Quality   2014 - Present
The Henry M. Jackson Foundation for the Advancement of Military Medicine  2008 - 2014
NK Holdings, LLC   2001 - 2008
American Society for Clinical Laboratory Science  2000 - 2002
Regulatory Affairs Professionals Society (RAPS)   1998 - 2000
American Kidney Fund  1994 - 1998

Skills
Management Consulting, Risk Management

Education
University of Baltimore
Master of Business Administration (MBA), Entrepreneurship/Entrepreneurial Studies/Technology

University of Maryland Baltimore County
Bachelor of Arts (B.A.), Health Science