Project Manager Medical Device

DONGNI LI, MS

Address: ** ******** ***, ******, ** 02148

E-mail: **********@*****.***

Tel: 832-***-**** (mobile)

F1 Visa, OPT starts August 2013

Education

January 2012--July 2013 GPA: 3.7 / 4.0

Master of Science, Regulatory Affairs of Drugs, Biologics and Medical

Devices Northeastern University Boston, MA

Courses: Introduction to Food, Drug and Medical Device Regulation;

Advanced Writing on International Biomedical Topics; Human

experimentation; New Drug Development; Biologics Development;

Medical Device Development; Clinical Drug Development Data

Analysis; Food, Drug, and Medical Device Law; Emerging Products in

Drugs/Biologics; Practical Aspects of Regulatory Development.

September 2006--July 2011

Bachelor of Science, Biological Engineering (with focus on Medicine)

College of Pharmacy, Jilin University, Changchun, China

Courses: Inorganic Chemistry, Organic Chemistry, Applied Psychology,

Medical Physics, Biology, Gross Anatomy, Histology, Cell Biology,

Microbiology, Genetics, Drug Design, Protein Engineering,

Biological Pharmacy, Pharmacology, Physiology, Biochemistry,

Internal Medicine, Drug Toxicity, Genetic Fermentation Engineering,

Cell Engineering, Regenerative medicine, Immunology, Tissue

Engineering, Disease Models, Health Law, Biological Electron

Technology, Drug Toxicity, Pathology, Analytical Chemistry, Medical

Mathematics, Medical Statistics, Embryology, Pathophysiology,

Pathological Anatomy, Internal Medicine,

Research Projects on Regulatory Affairs at Northeastern University

. November 2012, Analyzing the Changes of Section 510(k) of Food, Drug and

Cosmetic Act

As the project manager, I was in charge of a research group in analyzing

the latest regulatory compliance and followed by Investigation of its

impact on related companies;

. November 2012, Product and Regulation on Cord Blood Hematopoietic

Progenitor Cells

Gaining insight into the global situation of cord blood HPCs product for

deeper understanding of relevant regulatory procedures;

. October 2012, Research on MMR II Recall

As the project manager, I was in charge of a research group focusing

on history and adverse reaction of MMR II, and proposed a new general

strategy for the project and led to an interesting discussion in the

class;

. June 2012, projects Investigational New Drug (IND) & New Drug

Application(NDA)

IND: I composed a one-year plan specifying the activities needed from

the collection of chemistry information to recheck every file such as

complying with GLP to ensure the IND application complies with FDA's

requirements based on collection of necessary material and FDA

regulatory;

NDA: Using Onglyza (for treating type 2 diabetes) as a case study, I was

in charge of three critic sections: differentiators between Onglyza

and other products; clinical data; and interactions which the

company might have with the FDA.

Laboratory Research Experience

May 2010-July 2011, Internship in Proteomics Laboratory, Jilin University,

Changchun, China

Participated in the research of Ginseng's(plant): Protein extraction and

analysis with techniques of 2D-gel electrophoresis, Western blot, etc. and

published the paper;

Took part in the development of cosmetic using low protein extracted from

Ginseng stem

March, 2013 --present

Mainly Cell culture for nanotube's characterization and measuring, Webster

Nanomedicine Laboratory, Northeastern University, Boston

Laboratory technique

Two dimensional gel electrophoresis, Protein extraction from plant

(Ginseng), Western Blot, Cell culture, MTT, ELISA, PCR,

Publication

Sun LW, Ma PT, Li D, Lei XJ, Ma R and Qi C. Protein extraction from the

stem of Panax ginseng C. A. Meyer: A tissue of lower protein extraction

efficiency for proteomic analysis", African Journal of Biotechnology

2011:10(21): 4328-4333.

Sun LL, Li DN, Hemraz U, Fenniri H and Webster T. Rosette Nanotubes Enhance

Skin Cell Adhesion and Proliferation. Will present on AIChE 2013 Annual

Meeting.

Additional Experience

October 2009 - December 2009, Changchun University

. English Teacher for adult class

. Student Tutor for Entrance Examination

Interests and Hobby

Drawing: Designed and drew posters for most of the activities of Pharmacy

College

Calligraphy: Studied calligraphy from 8 years old and won many awards in

China.

Dancing: Choreographed all of the dance movements, responsible of clothing,

scenic arrangement and led our team participated in several dance contests.

Contact this candidate