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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.
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About the Cloud Engineer The Cloud Engineer will be instrumental in maintaining and optimizing the ACL’s cloud environment as part of the EITS project. In addition to infrastructure management, the Cloud Engineer will be responsible for monitoring system performance, conducting security assessments, and troubleshooting issues as they arise.
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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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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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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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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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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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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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Partner with IT and QA on the change management, release management, and ongoing validation of all Regulatory Operation computer systems. Support Acadia's regulatory systems portfolio including Veeva Vault Submissions, IQVIA RIM Smart, and other utilities and tools used in the management of regulatory information and submission production, partnering with IT, and vendors.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
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validation engineer regulatory jobs in Cranbury, NJ
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