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Job Details

Clinical Technical Writer

Madison, NJ, United States

Posted on
Jul 12,2019

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Clinical Technical Writer needs 2 years' experience in Regulatory Affairs experience Clinical Technical Writer requires: Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline 2 years of experience in pharmaceutical research and development or regulatory affairs 1 years of CMC regulatory experience is desirable Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions Strong working knowledge of manufacturing unit operations Familiarity with US and other international regulatory requirements for drug product dossier Clinical Technical Writer duties: Prepare, coordinate, and manage the chemistry, manufacturing, and control (CMC) documents for annual reports (IND and NDA). With supervision prepare CMC documents for use in routine US and ex-US regulatory filings. Provide guidance on use of submission document templates. Provide assistance on department related assignments and projects. Identify and communicate routine CMC issues. Collaborate with diverse functional groups to ensure fileability and acceptance

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