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Greater Boston Area United States

Submission Project Manager, Regulatory Affairs at Shire

Medical / Health Care / Pharmaceuticals

Over 7 years of Professional experience including 5 years of experience in providing Regulatory publishing services in pharmaceutical industry supporting eCTD Publishing and Submissions in Regulatory Operations Summary of Expertise • Highly experienced in the following tools: eCTDXpress, ISI Publisher, ISI Writer, ISI Virtual Link Manager, Liquent’s Insight Manager, Adobe Acrobat, ISI Tool Box, TrackWise (Registration Management), Documentum (First Doc), Global Submit Reviewer, Validate, SharePoint., Belgium checker, Extedo (EURS is yours), Lorenz eValidator, and eSubmitter. • Highly knowledgeable in Managing life cycle of submission documents in eCTD Submission format. • Expertise in u...