Medical Development

Yvonne Wu

*** ***** **** *****, **********, New 312-***-**** *********@*****.***

Jersey 07095

SUMMARY

Highly motivated writer of regulatory/clinical documents with fast learning curve

seeking medical writer position

EDUCATION

Ph.D. (June 2010) - Northwestern University, Evanston, Illinois (Feinberg School of

Medicine)

Dept. Cell & Molecular Biology. Dissertation: The Role of ?6?4 Integrin in

Epithelial Cell Motility

B.Sc. (May 2003) - Rensselaer Polytechnic Institute, Troy, New York (School of

Science)

Dual-Major: Bioinformatics & Molecular Biology, General Biology. Minor: Brain &

Behavior Psychology

Drug Information Association (March 2010) - Overview of Drug Development (webinar)

Drug Information Association (April 2010) - Development of a Clinical Study Report

(instructor-led course)

PROFESSIONAL EXPERIENCE

Consultant Medical Writer - Daiichi-Sankyo Pharma Development, Edison, New July

Jersey 2009 -

Worked with senior writers with clinical study protocols, protocol present

amendments, and marketing submission documents by coordinating document

review meetings, reconciling comments and edits from various functional

groups, etc. In addition, performed document QC review and obtained

signatures from approvers

Produced company's first global IB by collaborating with various functions,

compiling contributions of local and ex-US authors, and formatting the IB to

company standards

Writing an abbreviated CSR for an oncology study

Compiled and electronically published (using Adobe Acrobat and ISI Toolbox)

appendices for a CSR for an oncology study

Performed QC review of electronically published CSRs produced by contract

research organizations for completeness and adherence to regulatory

guidelines and company standards

Worked with senior writers in the US/EU and Japan to produce protocol and

CSR templates for global studies conducted in all regions

Supported the submissions of 2 INDs and 1 sNDA by electronically publishing

nonclinical reports, producing and/or formatting IBs, and checking bookmarks

and hyperlinks in an electronically published dossier

Technical support expert for document authors and approvers using a recently

implemented Documentum system to review, approve, and archive documents

Attended a series of company-sponsored lectures specifically designed to

introduce the various functions involved in drug development to entry level

contractors

Resident Research Assistant - Northwestern Univ. Feinberg School of Septembe

Medicine, Chicago, Illinois r 2003 -

Designed and implemented innovative strategies for the successful November

engineering of specialized skin and lung cell lines to investigate wound 2008

healing and cell motility

Managed technicians and mentored new students on laboratory procedures and

techniques

Led frequent discussions regarding various innovative findings in scientific

literature

Aided graduate students in other departments with alternative experimental

approaches

1 of a select group of 4 graduate students to showcase findings on

epithelial cell biology to members of the interdepartmental Tumor Invasion,

Metastasis, and Angiogenesis program

AWARDS, LEADERSHIP ACTIVITIES, AND PROFESSIONAL MEMBERSHIPS

Recipient - Oncogenesis & Developmental Biology Training Grant (Nat'l Cancer

Institute, Nat'l Institute Health)

Recipient - Howard Hughes Medical Institute Research Internship

Mentor - Women at Rensselaer Mentor Program

Upperclassman Representative - Chinese American Students Association, Rensselaer

Polytechnic Institute

Science Fair Judge - Chicago Public Schools, South Region H.S. Science & Math Fair,

Chicago, Illinois

Member - Drug Information Association

Charter Member - Beta Beta Beta (National Biological Honor Society, Theta Eta

chapter)

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