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Collaborates with professionals, health plan departments such as Claims and Medical Management, and the third party administrator staff and legal, as necessary, to investigate and facilitate resolution of individual grievances and appeals.
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Title: Specialist, QC Sample Management, Cell Therapy. The Specialist, QC Sample Management, Cell Therapy is responsible for performing routine management of in-process, final product and stability samples and QC data throughout the sample lifecycle from receipt to disposition.
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Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
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Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System ( TrackWise or Veeva), JMP, etc. Laboratory Information Management System (LIMS) Responsibilities:Accountable for end-to-end program management for biologics marketed product stability program, including: Stability product strategy: determines/communicates stability requirements ( Health Authority annual commitments, product/process change qualification batches, etc.
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Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
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Activities include (but not limited to) those associated with developing product stability strategy; stability data analysis/trending; and preparation, review and approval of stability protocols, reports and regulatory filings.
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Blue Raven Solutions, headquartered in Morristown, NJ and having decades of operating experience, provides tech-enabled, scaleable supply chain management solutions to over 80 OEM partners and a growing list of military customers including the Defense Logistics Agency (DLA), US Navy, US Army and more.
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This is a great opportunity for a new graduate i.e. undergraduate or recent graduate with a degree in Supply Chain Management, Industrial Design, Visual Arts, Finance, Accounting, Marketing or other relevant field of study.
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The role reports to the IEEE Executive Director and Chief Operating Officer and is a member of the Management Council, IEEE's executive staff leadership team. ●Preference for high-level association management experience, especially in a 501 (c)(3) organization and experience as the chief operating officer of a large association.
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Preparation of Schedule Projection (What-if) and Time Impact Analysis per Regional Project Control Manager AcceptancePreparation of Critical Path and Variance analysis reports for review with Regional Project Control ManagerCoordinate, develop WBS dictionary with Project Accountant Manager.
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5+ years of relevant Genomics or Synthetic Biology experience in a commercial role with a proven track record of success in account management, exceeding targets and driving revenue growth. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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Trinitas Regional Medical Center is pleased to offer several Centers of Excellence and specialized major services, including Behavioral Health, Cancer Care, Cardiology, the Connie Dwyer Breast Center, Diabetes Management, Maternal and Child Health, Renal Services, School of Nursing, Senior Services, Sleep Disorders, Women's Services, Wound Healing and more.
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Documentation: Prepare and review export documentation, including airway bills, commercial invoices, and export declarations. Proficiency in logistics and transportation management software.
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Expected to work with limited oversight from direct manager; but expected to identify and promptly escalate to management any critical issues related to stability program (e.g. potential impact to regulatory commitments, lab capacity, stability storage capacity.
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Program management – Deploy Social Sustainability programs in collaboration with external experts to support our strategic business partners’ capacity to drive social transformation on issues such as fair wages, gender or racial equity, ethical recruitment or just transition, co-designing practical, impact-driven solutions for the benefit of workers across globalized value chains.
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review management jobs Title: medical director Company: Meet in Iselin, NJ
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