R. STEPHANIE KONG

** ******** **., ****** ******, NJ 07076 908-***-**** accv8y@r.postjobfree.com

SUMMARY

Highly motivated pharmaceutical scientist with extensive experience in cross-functional R&D

discovery. Proven record of delivering drug candidates from discovery to development and regulatory

filing. Proficient interpersonal, communication, and presentation skills. A bility to balance multiple tasks

to meet priorities and timelines

HIGHLIGHTS

• Self-starter with knowledge of Regulatory history, ICH/GCP guidelines on Clinical Study Report, GCP,

clinical trial design and understanding of the logistics and work of the pharmaceutical industry through on

line training:

- FDA Law and Regulation

- Global Regulatory Strategy for Pharmaceuticals

- Introduction to Regulatory Affairs in the US and Canada

- Introductory Medical Writing

- Pharmaceuticals: Definition and Lifecycle

- Regulation of US and EU Biologics

- Role of the Regulatory Professional

- Understanding and Managing the US Clinical Trial Process

- Ethics

• Effective contributor to a number of preclinical study reports to support IND and NDA filing

• Preparation of key scientific data for journal articles, patents, poster sessions and oral presentation

• Co-authored multiple manuscripts and poster abstracts for internal and external publications

• Established standard operating procedures for technology platforms to enable HCV drug

discovery

• Served as a Single Point of contact for Merck biological reagents outsourcing projects and

chemical inventory system

EDUCATION

• Regulatory Affairs Certificate: Pharmaceuticals RAPS Online University

• Master of Science in Biology Seton Hall University, South Orange, NJ

• Bachelor of Science in Biophysics FuDan University, Shanghai, P.R.China

PROFESSIONAL EXPERIENCES

Merck Research Laboratories, Kenilworth, NJ

2011.10 – 2013.11: Scientist I /Infectious Disease group

Implemented a technology platform to perform in vitro translational PK/PD studies of HCV antiviral

drugs to support First-in-Human studies for key late stage HCV program; coordinated monthly cross-

functional reviews by key opinion leaders from clinical and DMPK department to perform due

diligence and acquire new technologies

R. STEPHANIE KONG

13 Fenimore Dr., Scotch Plains, NJ 07076 908-***-**** accv8y@r.postjobfree.com

Schering-Plough Research Institute, Kenilworth, NJ

1999.11 – 2011.10: Scientist I/Virology Department

Key contributor of the HCV drug discovery team that successfully delivered SCH503034 (Victrelis) which was

approved by FDA; supported clinical trials of MK-8742 phase 1b, MK-5172 phase 2 and Vaniprevir phase 2

and 3 studies; prepared preclinical pharmacology report for the IND filing of MK-8742 and MK-5172;

collaborated extensively with other teams such as high throughput screening, chemistry and DMPK to move

program forward

Merck Research Laboratories, Rahway, NJ

1998.8 – 1999.10: Contract employee/Vaccine Group

Participated in research and development of HIV-1 Vaccine; validated target vaccine in small animal

study under GLP; working knowledge experience in regulatory guidelines for compliance on

reportable data for vaccine studies

Seton Hall University, South Orange, NJ

1996.7-1998.7: Teaching Assistant/Biology Department

Examined the actions of Morphine on the brain-immune axis; tutoring undergraduate General Biology and Cell

Biology laboratory, including instruction experimental techniques and instrument utilization

Baylor College of Medicine, Houston, TX

1994.11-1996.6: Research Assistant/Neurology Department

Conducted Alzheimer’s Disease research; prepared regular progress reports for senior management ;

complied with good housekeeping and safety practices

AWARDS

• Young Investigator Travel Awards

Drugs of abuse, Immunomodulation & AIDS (Sixth Annual Symposium)

PROFESSIONAL AFFILIATIONS

• Regulatory Affairs Professionals Society

• Professionals in the Pharmaceutical and Biotech Industry

• Medical Science Liaison and Medical Affairs Networkers

PUBLICATIONS & PRESENTATIONS AVAILABLE UPON REQUEST

Contact this candidate