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Accountable for collaboration with cross-functional teams, including research and development, legal, regulatory affairs, and business development, to ensure IP considerations are integrated into product development and commercialization strategies.
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The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Development Operations and Services (DO&S) Portfolio Management Office (PMO.
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The position interfaces with experts in Process Development, Analytical Development, Manufacturing Sciences, and Technology, Operations, Quality, and Regulatory Sciences. Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with the regulatory strategy for cell therapy clinical CMC regulatory submissions based on high-quality technical reports.
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Position Summary: The Director, Clinical Systems and TMF Operations is a member of the Clinical Business Operations team within the Development Operations organization and is responsible to provide strategic leadership and oversight of Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CS+T) utilized across clinical programs.
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Serve as the analytical subject matter expert (SME) for internal product development, employing a range of analytical techniques such as chromatography (HPLC, UPLC, SEC), mass spectrometry (LC-MS), and other standard methodologies to support preclinical stage large molecule projects.
$156,133 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
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Attribute Sciences is responsible for developing and executing mechanism of action and characterization studies to support the development of gene-engineered T cell therapies. Experience with implementation and optimization of a broad range of in vitro cell-based and molecular assays is critical (especially multi-color flow cytometry and cell culture.
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The project(s) will be technical in nature and will support a development product program, with a particular focus on internal tech transfer coordination. Collaborate closely with development, manufacturing, quality, and regulatory teams to align tech transfer processes with project timelines and objectives.
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Lead the development and enhancement of iCare Lite, a cutting-edge digital health product, driving innovation in the healthcare industry. Creating strategic planning, product roadmap development, and business impact assessment for the iCare Lite product line.
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The Talent Development Specialist II is primarily responsible for the administration and facilitation (75%) of the Everest Core Professional Development programs. The Talent Development Specialist II is also aligned (25%) to the development of core and common corporate-wide Talent Development programs.
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Responsibilities are focused on the management and career development of the organization's Clinical Research Associate (CRA) workforce as well as providing oversight and coordination of project activities for CRAs assigned to FSP partnership.
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This individual will be responsible for delivering CMC documentation (Dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
$41.8 an hourExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Experience in ABAP (for SAP Integration) and Neptune DXP. Design and Build : You will design, build, and configure applications using Neptune DXP, leveraging its low-code and no-code capabilities.
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Our fully-accredited non-profit private school combines traditional academics with therapeutic intervention and pre-vocational skill development. Our Adult Services Program includes seven licensed community residences/group homes and two adult learning centers.
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The Executive Director of Patient Support Solutions is a member of the Market Access and Patient Support Leadership Team responsible for growing business with new and existing clients by driving supporting solution development & design, brand strategy, and ensuring Syneos Health is a preferred partner.
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