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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. 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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For this initiative, this position will facilitate all communications and program aspects, from coordination with the Office of Enrollment Management for student review, through to enrollment, bridge semester activities, transition, and degree completion.
$86,471 - $129,099Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Works independently, review data and demonstrated ability to recognize anomalous trends or results. Review and endorse change controls as required. Serve as stability subject-matter expert (SME) on project teams related to pre-market and post-approval changes.
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Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System ( TrackWise or Veeva), JMP, etc. Good organization skills and keen attention to detail Qualifications: (MS) or BS degree required with relevant cGMP experience in biopharma within a pharmaceutical manufacturing facility.
$64.15 - $69Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As the Underwriting Support Coordinator on the Compliance Review Team, you will be assisting the Underwriting Centers by reviewing and managing critical requirement documents relating to home inspections for compliance.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Meet with ABA Site Manager to review scheduled hours and ensure optimization of all supervision and parent training hours. Cortica is looking for a Part-time Board Certified Behavior Analyst (BCBA) to join its growing team.
$45 - $56 an hourPart-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Initiate change controls related to stability operations Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups.
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Maintains trademark portfolio management databases, including data entry, docket review, and preparation of reports for attorneys and business units. Executes domestic and international trademark screening and searching online, and conducts initial review of search results, to determine availability and scope of potential rights.
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Reporting directly to the VP/General Counsel, you will play a crucial role in providing comprehensive paralegal support for our legal department, with a focus on state licensing, intellectual property management, Sunshine Act reporting, contract review, etc., in support of our business and legal operations.
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Reviews alerts generated from STCs transaction monitoring system and escalates concerning activity for case review. LOCATION This position will be based entirely on-site in Somerset, PA. SUMMARY The BSA Analyst will support the Banks Bank Secrecy Act (BSA), Anti-Money Laundering (AML) and Counter Financing of Terrorism (CFT) program by adhering to policies, procedures, and controls, as well as assist in the detection and prevention of money laundering and suspicious activity.
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Oversee the commercial contract management team in the performance of contract maintenance operations for commercial and Medicare Part D contracts, including review and approval of rebate claims data and invoices.
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Based on supervision, observation, chart review and changes in the field develops and implements individual and departmental education plans. Other: This may include, but is not limited to airway clearance techniques; integumentary repair/protective techniques; cardiac rehab/medical monitoring.
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The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs. Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.
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Position Details As a Civil/Structural Engineer, you will conduct and manage investigations involving buildings, structures, and structural components, including structural analysis, damage assessment, building code compliance, lab and field testing of construction materials, and review of structural designs.
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review job Title: project Company: Dice in Somerset, NJ
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