... and global filing preparation, be responsible for strategically constructing submission dossier, and work to innovate in planning to expedite timelines and drive higher quality clinical ... of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development.Strategic Leadership: Integrating scientific rationale, regulatory requirements ...
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... of deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination ... of study and implementation plans and supporting third party vendor relationships.Work with fellow operational team members as well as cross functional team members (Medical Affairs ...
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Are you interested in a highly visible leadership opportunity that will allow you to develop and execute CMC project plans and accomplish strategic development objectives ... commercial supply for one or more high complexity assets.Develops the integrated CMC/supply chain strategy and plan (technical, industrialization and lifecycle) and the CMC budget ...
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... the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development.Ensuring alignment with and support to project ... strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP.Generating the data and evidence required to determine a medicine’s ...
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... process including the production of project quality plans and procedures; Undertaking all responsibilities for the QMS (Quality Management System) and ensuring compliance;Identifying ...
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... of staff and overhead spend. Suggest capital investments to improve manufacturing areas both in terms of efficiency and compliance. Ensure weekly and monthly production plans are met ... . Adherence to the manufacturing plan, investigating misses and putting in place necessary improvements to avoid recurrence. Role Requirements To be successful in your application ...
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; ensure appropriate investigations are carried out, and relevant care plans are put in place, including starting and monitoring medication under the supervision of a Consultant ... service user’s needs.Participate in the decision making process for treatment plans and therapeutic programmes, weekly MDT reviews, other multidisciplinary meetings, Mental Health Act ...
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... and schedules • Plan and manage travel logistics, both internationally and domestically • Plan and manage events and meetings, both internationally and domestically • Plan and manage meeting ... conferencing and Webex • Experienced in Concur (or equivalent) • Experience managing comprehensive international travel arrangements • Demonstrates the time management skills to plan manage ...
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... Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in developmentStrategic Leadership: Integrating scientific rationale, regulatory requirements, product ... development plan and commercial goals to optimize clinical study designs aligned with the IEP and CDPGenerating the data and evidence required to determine a medicine’s potential efficacy ...
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... team Senior Programmers and Principal Programmers support, guide, or make a major contribution to the planning and execution of multiple programming activities for GSK clinical trials ... . They are accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.This role will provide YOU ...
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