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Leidos has the perfect job for you in Borinquen, Puerto Rico! Perform individual and/or batch Primary Care Manager (PCM) changes, following the Military Treatment Facility (MTF) guidelines. Knowledge of TRICARE Overseas programs, Defense Enrollment Eligibility Reporting System (DEERS), DOES, and CHCS.
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Serve as voting member of the IACUC, participating in protocol review, semiannual facility inspections and program reviews, as well as review of animal welfare concerns and other IACUC business.
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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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Experienced Document Review Attorney – Remote Great opportunity for licensed attorneys with significant document review experience interested in quality focused eDiscovery. JOB DETAILS Project-based eDiscovery document review (litigation and/or investigation) Fully remote work environment.
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The Senior Manager, US Medical Review will sustain and promote Alexion’s professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech industry by providing high quality Medical Review of all material used by the Commercial and Medical teams.
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Minimum of 3-5 five years of relevant experience in Puerto Rican arts and culture and a professional and/or academic background in any of the following areas: public art, arts administration, curation, fine arts, mixed media, urban design, architecture, sociology, anthropology, urban studies, community development, or other arts-related disciplines.
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Graduate of an X-ray technician program accredited by the Joint Review Committee on Education in Radiologic Technology (JRCERT) or another accrediting agency approved by The American Registry of Radiologic Technologists (ARRT.
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Work with procurement team to review vendor and consultant agreements to validate funding and contract type are appropriate based on prime contract including subcontracts and materials purchases.
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Perform document review, study design, sample management, data review, risk assessment and trending analysis. Work with technical SMEs and Regulatory to review and author QC related sections of IND, IMPD, BLA/MAA and global regulatory submissions and provide support in addressing information requests.
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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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Oversees the management of study specific documents according to guidelines of the reviewing Institutional Review Board (IRB), NIH and/or study sponsor. Assists with the development of Institutional Review Board (IRB) submissions, and provides annual reports according to the reviewing IRB policies and procedures.
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Interpretation and/or collation and integration of draft elements (e.g., flow cytometry, rapid heme panel, cytogenetics, peripheral blood or bone marrow smear) of reports, including review of current and prior clinical and laboratory findings.
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Review daily cash and transaction reports , including for aggregate transactions, and prepare CTRs when needed. Review branch and system generated CTRs for completeness, accuracy and compliance and file.
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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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review puerto jobs Title: regional in Brookline, MA
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