
Rong Kong
Highly motivated pharmaceutical scientist with extensive experience in cross-functional R&D discovery. Proven record of delivering drug candidates from... | Scotch Plains, New Jersey, United States
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Rong Kong’s Emails rk****@ra****.org
Rong Kong’s Phone Numbers No phone number available.
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Rong Kong’s Location Scotch Plains, New Jersey, United States
Rong Kong’s Expertise 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. Highlights: • In-depth knowledge of medical/scientific and clinical research in pharmaceutical R&D setting • Thorough knowledge of 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 courses • Strong technical writing skills, drafted study reports intended for IND and/or NDA; prepared and reviewed clinical documents (protocol, IB, CSR, Briefing package etc.) • Proven strong data analysis and interpretation skills by preparing key scientific data for journal articles, patents, poster sessions and oral presentation • Solid knowledge of clinical trial operation: site selection-closeout, budget, monitoring, advertisement-patient recruitment, important documents (ICF, CRF, protocol etc.), study implementation • Established standard operating procedures for technology platforms to enable HCV drug discovery • Participate in day-to-day Regulatory Operations activities with a large emphasis on the development and implementation of systems and procedures used to support regulatory submission activities • Knowledge of IND, NDA and CTD with excellent computer literacy in MS-project, Power Point, document management systems, and ability to quickly learn new software, tracking tools and associated processes • Responsible for supporting the submission of regulatory documents through the FDA ESG (SPL, XForm, eSubmitter, etc.)
Rong Kong’s Current Industry Bayer
Rong
Kong’s Prior Industry
Merck
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Schering Plough Research Institute
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Regulatory Affairs Professionals Society
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Ab Science
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Bayer
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Work Experience

Bayer
Senior Regulatory Affairs Coordinator
Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Ab Science
Regulatory Affairs Assistant
Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Regulatory Affairs Professionals Society
Regulatory Affairs Certificate Program / Pharmaceuticals
Fri Nov 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Scientist I
Sat Oct 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Nov 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Schering Plough Research Institute
Scientist I / Research Associate
Mon Nov 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Contract Employee
Sat Aug 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)