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Mfg. Technology, Principal CMC Regulatory Support Associate IImClone Systems - Branchburg, NJIndividual will be a member of an interdisciplinary team that will provide support to the Regulatory Affairs (CMC) Organization. This teams primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplements and amendments. Additional responsibilities include assisting the RA (CMC) Group with the compilation of the responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and to keep to the... See job listing >6 days ago from ImClone Systems - Save - Block - Flag - More Tools...
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ImClone Systems
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Headquarters:
180 Varick St Fl 6
New York, NY 10014
Phone: 212-645-1405
http://www.imclone.com - Line of Business: Commercial Physical Research Mfg Biological Products Mfg Pharmaceutical Preparations
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Key Numbers:
Company Type Public (IMCL:NMS) Company Revenue $100M - $500M Company Size 500 - 1000 employees
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