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experience in audits with a background in GCP, PV, GLP, Process or other related quality areas Expertise in 1+ major areas (Doc, PCO, Disease Area, etc.); and 2+ minor specializations OR 2+ major and 1+ minor
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withstanding regulatory scrutiny. This position will focus primarily in Trial Master File Operations. Facilitate the execution of the TMF Operations' activities to enable complete, compliant and consistent study
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throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post-approval submissions
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for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and
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, and support Pre & Post deal analytics, Formulary tracking, Market Dynamics, and Op Planning BASIC QUALIFICATIONS Candidate demonstrates a breadth of diverse leadership experiences and capabilities
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, e.g., GDMS. Finalize documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc.). Manage the document status in
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The Fred Hutchinson Cancer Center (Fred Hutch) and the University of Washington (UW) invite nominations and applications to lead the Fred Hutch Breast Cancer Program. The position will be dual
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, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc) Support country specific ICD review and deployment when applicable Ensure follow up activities completion post PTA and SIV to ensure site readiness
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Manager may be responsible to independently take on the closing out of one or more studies post database lock. Provides back up to or takes on the responsibilities of Global Study Manager as needed
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, Excel, Word, Outlook and PowerPoint. Excellent interpersonal and organizational skills . Nice-to-Have Master's degree (MA/MS/MBA) and 7+ years of experience . Doctorate (PhD/PharmD/JD) and 4