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Your primary responsibility will be to design, develop, and improve next generation sequencing (NGS) techniques to characterize CRISPR guide RNAs from research and development into a regulatory environment.
$100,000 - $115,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
$191,335 - $247,610ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Key Responsibilities:Apply automation and high-throughput technologies for mammalian cell line generation and process optimizationLead end-to-end Cell Line Development pipeline projects, including activities from vector design and construction to clonal cell lines ready for Master Cell Bank generationSupport process improvements for increased speed and efficiency to generate highly productive, high quality, robust cell lines that meet all regulatory requirements with high quality documentation.
$154,020 - $199,320Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Camio already has a number of interesting case study customers, including Stanford University (DOD), Altria (regulatory compliance) and Delta Airlines (via NewRest/TSA for safety risk). Additionally, expertise in navigating complex regulatory landscapes and understanding the specific needs of governance, risk, and compliance applications would be valuable.
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
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We are looking for a Forensic Technologist to join our eDiscovery and Information Governance Legal Team. In your role as a Forensic Technology Lead, you will focus on discovery/disclosure efforts in the various phases of the EDRM model for litigation and regulatory matters, investigations, and all other matters requiring the identification, preservation, collection, processing, and production of data.
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Support the oversight of drug safety/pharmacovigilance service providers to ensure the collection, processing, and reporting of adverse events reports in compliance with global regulatory requirements.
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Manages internal Know Your Client "KYC" for new client onboardings, articulating BSA / AML requirements to client based on legal entity type; supports clients in triaging additional information needed to satisfy regulatory requirements.
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Licensed mental health professional as confirmed by state regulatory/licensing board (, LCSW, MFT, RN, or LPCC) from the state of operation. Licensed mental health professional as confirmed by state regulatory/licensing board (, LCSW, MFT, RN, or LPCC) from the state of operation.
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This position will be responsible for leading the programming aspect of a project for all programming deliverables from the single study through to regulatory approval. The Manager, Statistical Programmer will be expected to provide timely support to the study team on all programming matters according to project strategies.
$160,000 - $175,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
$166,800 - $226,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge and understanding of national and international regulatory guidelines and drug safety practices. Maintain knowledge of global regulatory authority regulations (especially FDA and EMEA) and apply appropriately to all activities.
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You will navigate & interpret complex Federal regulatory frameworks ( FedRAMP, DoD SRG, & CMMC) in order to provide practical guidance on technical architecture, documentation & operational concerns, and sustainable processes that will allow us to continue to grow quickly & efficiently.
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Willingly assists as needed in all peri-anesthesia settings including the preoperative area, PACU, and the Endoscopy PACU. · Maintains the principles of confidentiality and HIPPA. Understands the legal/regulatory requirements related to the release of information.
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Prepare regulatory submissions, and ensure institutional Review Board renewals are completed. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
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regulatory job Title: regulatory affairs project manager Company: Gpac in Foster City, CA
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