BAS Regulaotry/Technical Writer - (Princeton, NJ)
The selected applicant will have Regulatory Report Responsibilities supporting BioAnalytical Sciences (BAS) in authoring Clinical and Non-Clinical Bioanalytical Study Reports (BSR) for registration filings for small and large molecules through the application of worldwide guidelines. Assignments include technical writing support for BSR report components, providing CARA support in building structures, assigning and approving tasks, creating publications of submissions, ensuring PRISM compliance, and maintaining model document report templates. Strong Microsoft skills in ms word and ms excel, expertise to analyze Watson data, and present data for submission readiness is required. Position responsibilities: * BS or MS degree in Biology, Science, Mathematics or related position with a min of two years of background * Background authoring with templates, tables and graphics * An understanding and knowledge of pharmaceutics, the development process, and regulatory guidelines. * Background in data analysis.
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From TopUSAJobs - 1 month ago