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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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, 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
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documentation systems Nice-to-Have Master's degree Experience engaging in the external regulatory and pharmaceutical environment 2+ years of hands-on CMC authoring experience (investigational, initial
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deliverables remain on target to meet internal and external deadlines. The GLL serves as the GLM primary point of contact for Labeling Team members (e.g. Regulatory Strategist, Safety Risk Lead, Functional Line
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ROLE SUMMARY Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic
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directly impact patients. What You Will Achieve The primary responsibility of this position is to provide logistical support to clinical study teams for Vaccine Research and Development (VRD) clinical and
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first in human (FIH) through proof of concept (PoC) studies, including proof of mechanism (PoM) and early signals of efficacy (ESoE) studies in a given therapeutic area. The primary therapeutic areas
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recommendations Demonstrated ability to manage vendors to ensure effective project delivery Nice-to-Have Master's degree Experience in quality control and/or quality assurance within the pharmaceutical industry
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-to-Have Master's degree Experience engaging in the external regulatory and pharmaceutical environment 2+ years of hands-on CMC authoring experience (investigational, initial registrations or post-approval
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of project planning and resource forecasting tools and systems (e.g. Microsoft Project, Planisware)) Rapidly mastering new software tools Nice-to-Have Project Management for Professionals (PMP) Certification