Sales Representative Pharmacy Technician
Resume:
Professional Summary
Fifteen years experience in pharmaceutical sales, market research, consulting, and regulatory affairs. Twenty-five years as a Registered Pharmacist in retail, hospital, home infusion, hospice, and long-term care pharmacy environments.
Resume Objective
To provide evidence of a long-term successful working knowledge of CFRs necessary to obtain FDA approvals of a new dosage strength, all labeling components, and adverse reporting data compliance.
Career Highlights
Providing pharmaceutical care plans for patients in retail, hospital, and specialized pharmacy environments.
Researching, writing, and submitting 505 (b)(2) NDAs and ANDAs.
Researching and writing support documentation for medical expert witnesses relating to toxic torts and pharmaceutical product liability.
Retail and hospital sales representative for Eli Lilly and Company.
Designing, developing, and teaching a college diploma, Certified
Pharmacy Technician (CPhT) Program.
Professional Experience
REGULATORY AFFAIRS, 2005 - 2010
Project Manager, Nephron Pharmaceuticals Corporation, Orlando, FL
Write and submit 505(b)(2) New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Supplemental Applications, all in eCTD.
Researched, wrote, and submitted four Labeling Supplements involving major labeling changes and a Patient Package Insert, all approved.
Researched, wrote, and submitted a major Labeling Supplement for a proprietary trade name and alternative API source, approvals pending.
Submitted Medical Device to EU; application pending. Provide medical /scientific affairs services to physicians, pharmacists, and other healthcare professionals.
Research and write all of the product complaint investigations.
Review and approve all of the labeling components: package inserts, foil pouches, product cartons, and patient instructions.
CHAIRPERSON, PHARMACY TECHNICIAN PROGRAM, 2002 - 2005
Remington College, Tampa, FL
Design and develop the pharmacy technician program including curriculum, course objectives, syllabi, daily lesson plans, examinations, lab exercises, and grading policies.
Identification of, and coordination with, retail, hospital, and home infusion pharmacists to provide student externship sites.
Administrative responsibilities for the program and supervision of two certified pharmacy technician instructors. Prepare the students for the successful completion of the national Pharmacy Technician Certification Exam.
Professional Experience (continued)
CONSULTANT PHARMACIST, Tampa, FL, 2001 - 2002
Preparation of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for pharmaceutical manufacturers.
Provide support documentation for medical expert witnesses relating to toxic torts and pharmaceutical product liability.
Research and analyses of clinical literature and adverse medical events (AMEs) databases, both national and international.
Provide regulatory guidance for resolution of FDA violations.
REGISTERED PHARMACIST, Tampa, FL, 1989 - 2001
Provided pharmaceutical care plans for patients in retail, hospital, long-term care, hospice, home infusion, mail order, respiratory care, and compounding pharmacy environments.
Responsibilities included dispensing, consulting, and pharmacokinetic dosing.
ELI LILLY AND COMPANY, 1979 - 1989
Specialty Sales Representative, Clearwater, FL
Sales Training, Market Research, Indianapolis, IN
Hospital Sales Representative, Miami, FL
Retail Sales Representative, Pensacola, FL and Queens, NY
CHATEAU CHEMISTS, Woodmere, NY, 1976 - 1979
Registered Pharmacist – Rx compounding, dispensing, drug interaction surveillance.
Education
College of Pharmacy
St. John’s University
B.S. Pharmacy, magna cum laude, 1976
Graduated second in class of 120
GPA 3.73
Professional Associations
Co-founder, Pasco-Hernando Pharmacy Association
Florida Pharmacy Association
Regulatory Affairs Professional Society (RAPS)
Personal Achievements
Scholarship award every year in pharmacy school
Recipient of Eli Lilly and Company Achievement Award
Anthony J. Montebovi Medal for Medicinal Chemistry
President, Rho Chi Honor Society
Director, St. John’s University Drug Information Service
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