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The Utilization Review Specialist establishes a file on all incoming clients with insurance and maintains authorization for reimbursement from pre-certification through continuing stay reviews through discharge or referral.
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Cell therapy, t cell, GMP, batch record, batch record review, biologics, tcr, validation, manufacturing technician, Lab Technician, Laboratory Technician, cell biology, flow cytometry. Performs batch record review, procedure revisions, and work order generation.
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Author and review drug substance CMC Module 3 sections including regulatory investigational (IND/CTA), registrational (NDA/MAA), and post approval submissions. Address technical and quality issues/investigations (Deviations, OOS, OOT) at CMO’s to assure GMP compliance prior to QA release; utilize IST quality systems to document review and oversight.
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Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc. Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objectives (through Medical Monitor/PPL and other stakeholders, as appropriate.
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Preferred experience in hospital discharge planning, long term care facility, community health or utilization review. The Care Transition Specialist is responsible for acting as an advocate for patients and patient families and strives to support Newton Wellesley Hospital's aim for high quality care, high customer satisfaction, and optimal resource management.
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Perform review of site plans and documents as they relate to construction projects, utility installations, road permits, stormwater mitigation and work within the right of way. Engineering work involving surveying, construction inspection, plan review, coordinating permits, and preparation of engineering drawings, cost estimates, bid documents, and all other related work, as required.
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Review CMC supporting documents (GMP certificates, Manufacturing/Import Authorization, CoA, QP declarations, MBR) and request these documents from the appropriate associates. Review CMC section of submission dossiers for clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for development compounds.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving. Maintain and review key clinical documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g., for CSR appendices publishing.
$165,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Compile information for client presentations, shop drawing review, and contract administration for the design of substation. Perform or oversee quality review of above facets of substation design.
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Lead the review of XBRL tagging, as required. Identify and implement opportunities for operational improvement and efficiency Prepare and fully own executive ready presentations and lead conversations with executives, including CFOs. Ensure all transactions are accounted for in accordance with U.S. GAAP and perform/review SOX Controls, ensuring a control environment Prepare SEC reporting filings including press releases, Forms 10-Q, 10-K, 8-K and Annual Report.
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Oversee print editorial calendars for MIT Technology Review and MIT Alumni News. Set deadlines, check in on story progress, provide frequent status updates to the editorial director, run a weekly planning meeting, anticipate digital art or social needs early in the process.
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Review instructions from dispatchers and other transportation employees, and discuss with locomotive engineer. A conductor's primary responsibility is to safely coordinate train crews on a freight train, place rail cars to facilitate loading and unloading, and makeup/breakdown trains in a rail yard, customer facility or similar locations.
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RMR principally invests in hotels through Service Properties Trust (NASDAQ: SVC) a real estate investment trust that owns 220 hotels located throughout the United States, Ontario, Canada, and Puerto Rico and net leased retail properties; and Sonesta International Hotels and Resorts.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Perform data review via listings and EDC system, issue and resolve queries. Reporting to the Chief Development Operations Officer, the Director, Clinical Data Management, is a newly created role to head the Data Management function at IDRx. The Director, Clinical Data Management will help lead clinical trials and provide oversight for outsourced clinical data management activities by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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review puerto jobs Title: regional in Weston, MA
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