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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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Expertise, in-depth hands-on experience is expected in genomics platforms (NGS, qPCR, variant analysis platforms) for assay development, qualification/validation, troubleshooting, and reviewing run QC data.
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Expertise and demonstrated ability to develop assays, oversee assay validation inhouse or with external vendors, develop appropriate controls/ QC methodology, oversee clinical sample analysis and assay performance and help develop and deliver program genomics biomarker strategic plans.
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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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 2 months 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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The regulatory reporting team works closely with other internal teams including investor services, fund accounting and risk analytics to prepare CPO-PQR, Form PF, 13F, AIFMD and MMF filings on a quarterly, semi-annual and annual basis.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer); Catalent Pharma Solutions in Princeton, NJ is hiring a Manufacturing Science and Technology (MSAT) Process Engineer who provides technical support to Princeton, NJ Facility (CPNJ) Manufacturing processes in a GMP environment.
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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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Certification as a building official, planner, or professional engineer. Some of the challenges include working to implement new state regulatory requirements in a way that balances regulatory needs with maintaining affordability of housing.
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Responsible for accurately maintaining legible and accurate records, required logs, books, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
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AWS Certified Solutions Architect Professional or AWS Certified DevOps Engineer Professional. AWS Certified Solutions Architect Professional or AWS Certified DevOps Engineer Professional. Develop and maintain Infrastructure as Code (IaC) using tools like AWS CloudFormation, Terraform, and Ansible.
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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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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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Assist the MSA TA Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS Drug Development and WWPS.· Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
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validation engineer regulatory jobs in Monmouth Junction, NJ
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