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Senior Manager, Regulatory CMC
ImClone Systems Incorporated - Bridgewater, NJ

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GENERAL SUMMARY:
The incumbent is responsible for maintaining competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards, with an ability to evaluate same for impact on tactical operations. Good technical knowledge, provides committed, value-added effort in support of development projects and approved products. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents ...

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