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Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development). This includes but is not limited to responsibility for genomics and gene expression profiling (GEP) biomarker assay technology/ platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation and/or execution of biomarker analysis for BMS translational medicine and clinical programs.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$207,763 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience with Agile framework, DevSecOps processes, knowledge of cloud security, GxP, GDPR and other relevant regulatory compliance. Your Role : We are looking for an innovation-centric Senior Software Engineer, Application Development, R&D Digital Products to join our IT R&D (Research & Development) Team who is passionate about Digital Transformation in modern environments.
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Withum's Forensic and Valuation Services practice pride themselves in understanding their clients' business strategy and needs; assisting companies in meeting business requirements related to valuation, risk management, transfer pricing, economic analysis, and model validation.
$100,000 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Join Genmab as Senior Software Engineer, Application Development, R&D Digital Products as part of our IT & Digital Team and become a key player in revolutionizing antibody-based medicines for cancer and serious diseases.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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The Release Train Engineer will lead Agile/JIRA adoption for a portfolio of tests focused on data testing (testing that evaluates enterprise data across the Bank’s data lifecycle, including capture, transport, and use, and provides critical insights into data accuracy, completeness and fitness for purpose, as well as the data health of bank data domains and in-scope processes and controls.
$132,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Researches design options and documents findings for Project Designer/Engineer. Selects equipment based on recommendations of the Project Designer/Engineer and fills out equipment schedules.
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Overview Princeton Plasma Physics Laboratory is seeking an Alternating Current (AC) Power Electrical Engineer with experience in design, procurement, commissioning, operation, and management of electrical AC power systems and associated equipment to join our staff in the Facilities Engineering Division.
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STV is seeking highly motivated Civil/Water Resources Engineer for positions in our Lawrenceville NJ, Newark, NJ, and Philadelphia offices, with experience public transportation improvement projects for NJDOT, SJTA, NJ Turnpike, PennDOT, and other agencies.
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This Opportunity WSP is currently initiating a search for a full time Senior Water Resources Engineer to work in either our Lawrenceville, Morristown, NJ or Philadelphia, PA offices. Comply with regulatory requirements pertaining to the data integrity, documentation, procedures, training, monitoring systems, and record compliance and retention.
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How you’ll make an impact: As a Staff ML Ops Engineer at SiriusXM, you will be a key player in our Data Platform Team. Your role will be pivotal in deploying, managing, and optimizing machine learning (ML) models, leveraging advanced tools like Databricks and MLFlow.
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To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
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validation engineer regulatory jobs in Rocky Hill, NJ
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