George A. Quaye Jr.
* ****** ***** ************, **, 08081 202-***-****
*************@*****.***
PROFESSIONAL EXPERIENCE
Pharmaceutical Trademark Development and Regulatory Review CONSULTANT,
Cherry HILL, NJ
Freelance Consultant Apr 2012 - Present
Utilized specialized knowledge of US, EMA, and Health Canada regulatory
processes to evaluate name candidates for drugs in Phase II and III of
clinical trials.
Managed drug safety naming projects and provided regulatory
guidance/submissions for clients to submit name candidates to government
agencies such as the FDA, EMA, and Health Canada.
Coordinated with Market Research Team to conduct surveys and facilitate
expert panel groups.
Utilized drug references including Micromedex, ChemIndex, Drugs @FDA, Facts
& Comparisons, and FDA Orange Book to conduct searches.
Analyzed market research data and prescription studies to determine level
of risk for each name candidate in the study.
Prepared and coordinated detailed analysis of each name candidates
performance within the study.
Provided clients with recommendations on which name candidates would have
the best chance of being approved by the FDA, EMA, and/or Health Canada.
Prepared regulatory documents for clients to use for submissions to the
FDA, EMA, and Health Canada.
Utilized working knowledge of regulatory process to develop name candidates
for drugs in Phase II and III of clinical trials.
Utilized pharmacy knowledge to create unique name candidates to avoid
medication-dispensing errors.
Drug Safety Institute, A Division of Brand Institute, Inc., Largo, MD
Drug Safety Evaluator, Apr 2004 - Apr 2012
Utilized specialized knowledge of US, EMA, and Health Canada regulatory
processes to evaluate name candidates for drugs in Phase II and III of
clinical trials for numerous companies including AstraZeneca, Bristol Myers
Squibb, Genentech, GlaxoSmithKline, Novartis, Johnson & Johnson, Merck &
Co., Pfizer, Roche, and Sanofi-Aventis.
Managed drug safety naming projects and provided regulatory
guidance/submissions for clients to submit name candidates to government
agencies such as the FDA, EMA, and Health Canada.
Coordinated with Market Research Team to conduct surveys and facilitate
expert panel groups.
Utilized drug references including Micromedex, ChemIndex, Drugs @FDA, Facts
& Comparisons, and FDA Orange Book to conduct searches.
Analyzed market research data and prescription studies to determine level
of risk for each name candidate in the study.
Prepared and coordinated detailed analysis of each name candidates
performance within the study.
Provided clients with recommendations on which name candidates would have
the best chance of being approved by the FDA, EMA, and/or Health Canada.
Prepared regulatory documents for clients to use for submissions to the
FDA, EMA, and Health Canada.
Daily interactions with team members from various departments regarding
nomenclature and regulatory processes.
Brand Institute, Inc., MIAMI, FL
Creative Nomenclature Pharmacist, Mar 2001 - Apr 2004
Utilized working knowledge of regulatory process to develop name candidates
for drugs in Phase II and III of clinical trials.
Worked on nomenclature projects for numerous pharmaceutical and biotech
companies.
Utilized pharmacy knowledge to create unique name candidates to avoid
medication-dispensing errors.
Responsible for monitoring newly created name candidates versus existing
drugs.
Performed trademark screens and sound-alike/look-alike investigation to
evaluate and eliminate potential name candidates.
Provided team members with important pharmaceutical knowledge in order to
successfully created quality name candidates.
Daily interactions with team members from various departments regarding
nomenclature process.
Researched and answered drug information questions.
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WALGREEN'S PHARMACY, FT. LAUDERDALE, FL
Staff Pharmacist, May 1999 - Mar 2001
Responsible for pharmacy staff to provide quality pharmacy care for
patients and customers.
Exceeded prescription count goals and sales goals.
Researched and answered drug information questions.
Assessed drug-drug interactions in patients' current therapy.
Counseled patients on how to use their medications.
Interacted with doctors, nurses, and insurance companies on a daily basis.
Responsible for inventory control.
Maintained excellent customer relations.
Education
UNIVERSITY OF THE SCIENCES IN PHILADELPHIA, Philadelphia, PA
Masters of Business Administration in Pharmaceutical and Healthcare
Business, Expected Graduation May 2015
Philadelphia College of Pharmacy and Sciences, Philadelphia, PA
Bachelor of Science Degree in Pharmacy, May 1999
Additional Skills
PC & Mac Computer Skills
Proficient in Microsoft Office (Word, Excel, Powerpoint, Outlook)