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FDA's Office of New Drugs

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Mile Square Health Center

Chicago, Illinois

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Nestle Health Sciences

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Director, Regulatory Medical Writing
Director, Regulatory Medical Writing   As the Director, Regulatory Medical Writing, you will be responsible for overseeing, authoring, and editing of clinical documents (e.g., CSR, protocols, IBs), regulatory agency briefing documents and response documents, periodic safety reports, as well as marketing applications (BLA, NDA, MAA, NDS), and investigational applications (IND, CTA) for our development programs providing regulatory compliant documents with consistent messaging and use of program-specific technical terms resulting in well written, reader-friendly documents and applications.   Good things are happening at Omeros!   Come


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