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Support trial study start-up phases (support in writing study protocol, identification of investigators and KOLs, CRF review, Investigator brochure review, FDA/CA & IRB/EC assistance, support on medical and scientific questions/issues during trial follow-up phase.
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Senior Quality Specialist will be the SME for the quality systems such as Document Management, Artwork review, USP Compendial methods and management of reference standard. Review and approve ELM artwork processes and artwork verification.
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The Associate Director will also be responsible for the timely completion of monthly financial closing and management reporting; partnering in the preparation and review and quarterly filings (10-Q and 10-K), satisfying internal and external audit requests, and preparing and maintaining Sarbanes-Oxley (SOX) documentation.
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Conduct in-home assessments including an evaluation of past medical history, review of systems, medication reconciliation, vital signs, and comprehensive physical exam. Experience in gerontology, cardiology, internal medicine, or endocrinology.
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Supporting validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities. Assisting in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation.
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Help to organize quarterly business reviews and periodical meetings to review OEM sales metrics and areas for improvement. Review device COGS and pricing strategy to maximize Verizon sales and meet annual CV and sales metrics driving subsidy avoidance for VBG.
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Review CEC/DMC/Clinical trial reports. Lead literature review within a therapeutic area and translate evidence into comprehensive materials for marketing groups. Assist QS and engineering department in creation of risk management documents and IFU review.
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Author and review of Quality Management SOPs, test methods, and Specifications in the electronic document management system. + Review of Batch records for assigned product portfolios, which includes initiating and reviewing Investigations, CAPAs, Change Controls, etc.
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Conduct continuous review and evaluation of developments within the Duck Creek Technology Product Roadmap, as well as major industry trends, including Digital Transformation, InsureTech, AI/Machine Learning etc.
$172,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Where permitted by federal or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances: Amphetamines, THC (marijuana), cocaine, opiates, phencyclidine.
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Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
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Create and maintain federated models for many purposes, such as PE review models, field inspection models, punch list background models, and field instruction models. General review and documentation of design documents and coordination conflicts.
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Hand and Stone Franchise Corp. does not accept, review or store my application. Achieve sales goals as outlined by spa management. Hand and Stone Franchise Corp. does not accept, review or store my application.
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Collaborate with Translational Scientists, Companion Diagnostic Scientists and Clinical Scientists and Operations Leads in the review of clinical protocols, laboratory instructions, investigator training, clinical sample analysis, archiving of biomarker test results, and regulatory submission activities for Daiichi Sankyo clinical development.
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The Quality Specialist supports the Business Units, by attending Daily Operational Review (DOR), supporting Local Management of Change (MOC), Quality Monitoring System (QMS) review and implementation, Non-Conformance Investigations, Client Continuous Excellence (NCE) support throughout the factory, and other quality tasks as needed.
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review job Title: manager project in Bridgewater, NJ
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