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Medical Manager

Location:
Morristown, NJ
Posted:
October 24, 2014

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Resume:

SUMMARY OF QUALIFICATIONS:

. *+ years of Medical Affairs experience in the Pharmaceutical

Industry, including 6+ years of Medical Information and 3 years in

Pharmacovigilance.

. Excellent writing skills with expertise in writing medical

narratives, narratives for periodic adverse drug experience reports

(PADER), drug safety conventions and company authored standard

response documents.

. Recipient of Stellar Performer Award for Drug Utilization Review

(DUR) at Medco Health Solutions (MHS).

. Responsible for DUR proposal that resulted in multi million dollar

cost savings for company.

PROFESSIONAL EXPERIENCE

SANOFI

Bridgewater, NJ

Manager, Medical Information Operations

January 2012 to present

Roles and Responsibilities

. Responsible for oversight of the Medical Information Outsourced

Center (MIOC) through utilization of technology tools, regular

and ad hoc communications.

. Manage the written dissemination of general product information

correspondence to both external customers and internal customers

utilizing accurate, complete, and fair balanced evidence based

information.

. Participate in the management of research and literature

evaluation and preparation of standard documents for use in

addressing Medical inquiries.

. Responsible for handling escalated inquiries and assuring that

training is regularly provided to the MIOC.

. Assist the Medical Information Services Head as necessary in

managing reports and providing an opportunity for growth and

development.

. Provides tactical implementation of strategic plans within MIS

and ensures that all activities are conducted within an optimal

regulatory framework.

. Develop relationships with other departments within Medical

Affairs.

Associate Safety Specialist, US Drug Safety September 2008

to December 2011

Roles and Responsibilities

. Responsible for identifying clinically significant information

missing from initial reports and facilitates its collection.

. Summarize the information in a clear and concise narrative for data

entry.

. Enter domestic adverse event data (from both spontaneous and

clinical trial reports) utilizing controlled vocabularies coding

(currently: MedDRA).

. Subject matter expert for Cardiovascular and Internal Medicine

products.

. Assist in aggregate report preparation for Periodic Adverse Drug

Experience Reports by preparing narratives, demonstrating best

practices.

. Maintain comprehensive, safety knowledge of assigned products

through review of global aggregate safety reports and review of

scientific literature.

Medical Information Specialist- US Drug Safety June 2005

to September 2008

Roles and Responsibilities

. Possess scientific knowledge focus on company products and related

therapeutic areas

. Provide evidence based information from clinical trials, published

medical literature and FDA approved product labeling to Health Care

Professionals and Consumers on a timely basis

. Identify and report adverse events

. Utilize standardized responses in providing response to inquiries

. Develop and maintain ongoing relationships with Medical Affairs

functions, through appropriate familiarity with current literature,

attendance at meetings and professional relationships.

MEDPOINTE PHARMACEUTICALS, Somerset, NJ

Manager, Medical Communications

Feb 2005 to April 2005

Roles and Responsibilities

. Respond to medical inquiries from external and internal customers.

. Develop verbal, electronic and written responses to healthcare

professionals and consumer inquiries as needed.

. Implement programs to leverage customer contact towards improving

business.

MEDCO HEALTH SOLUTIONS

Parsippany, NJ

Registered Pharmacist

October 1999 to August 2004

Roles and Responsibilities

. Perform Drug Utilization Review (DUR), Seniors DUR of patient cases as

well as presentation of analytical Retro Drug Utilization Review

reports.

. Responsible for Order Completion of fax and mail in prescriptions and

performing doctor calls of the same.

. Certified In-House Trainer

SKILLSET

. Experience using Siebel, Documentum, Clintrace, AWARE, Clint, COGNOS.

EDUCATION

Rutgers College of Pharmacy: Bachelor's of Science Degree in Pharmacy, May

1993

Shenandoah University: Doctor of Pharmacy (PharmD), December 2010.

PROFESSIONAL AFFILIATION

. American Pharmacists Association (APhA)



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