Post Job Free
Sign in

Health Sales

Location:
Winslow Township, NJ, 08081
Posted:
August 27, 2013

Contact this candidate

Resume:

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.

[pic]

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)



Contact this candidate