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regulatory affair

Location:
United States
Posted:
February 18, 2012

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Resume:

SHUZHI ZHANG

** ***** ******, *** #*, Malden, MA, U.S.A. 02148

617-***-****

*****.****@*****.***.***

EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices April 2012

Coursework: Advanced Writing, Practical Aspects for Regulatory Compliance

Southern Medical University Guangzhou, China

Bachelor of Science in Nursing July 2009

Coursework: Medical Nursing, Surgical Nursing, Physical Assessment, Nursing Care for Child and Infant

ACADEMIC PROJECT

Imitation of drug manufacturing process May 2011

Practiced how to comply GMP during the process of making “drug cake”

Obtained basic requirement and elements of preparing batch record

Became familiar with the usage of deviation form and procedure

Preparation of SOP April 2011

Composed a simple SOP individually

Created a basic SOP sample including related elements for the future use

Paper research Sep. Dec. 2010

Learned the Chinese clinical trials and related regulations and the current problems, finished the paper The Ethical Challenges and Solutions for Chinese Regulations of Clinical Trials

VOLUNTEER ACTIVITY

Horizon for Homeless Children, Roxbury, MA Jan. –Nov.2010

Corresponded with other volunteers and teachers to set up various activities for the children

Demonstrated to the children what is good table manners and led them to do it

Read them the books, helped them recognize different colors, shapes and sounds

Taught them how to control the negative emotions, be kind to their friends and share the toys and books with friends

CERTIFICATE

Standard First Aid, CPR-Adult, Infant & Child, AED-Adult March 2011-2013

Conducted by American Red Cross of Massachusetts Bay

SKILLS

Computer: Excel, Word, PowerPoint, Adobe Photoshop, Statistics (SPSS)

Language: Mandarin (fluent), Cantonese (fluent), English



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