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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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The Core laboratory functions include technical, regulatory, and clinical oversight of core laboratory functions of clinical chemistry, point-of-care, laboratory information systems/informatics, mass spectrometry, immunology and routine hematology.
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Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
$73 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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O Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology, or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist, or clinical laboratory scientist.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP, and behavioral health, as well as the associated and relevant federal, state, and local regulatory entities.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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O Familiarity with pharmaceutical informatics standards like CDISC and MedDRA. o Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave. We are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and digital data/imaging monitoring, and data cleaning process efforts that occur within the Biomeasures Endpoints and Study Technologies (BEST) projects.
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Maintain a safe work environment and wear appropriate personal protective equipment Requirements: Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements.
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The Financial Planning & Analysis Consultant is a member of the Treasury organization which is a dynamic team of individuals with diverse backgrounds that are focused on maintaining a balance between high and sustainable returns for policyholders, and a strong capital position, while enabling MassMutual to take advantage of growth opportunities; within internal, regulatory, and rating agency constraints.
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The individual in this role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen's services and commercial products in compliance with company policies and procedures and regulatory guidelines.
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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is also responsible for addressing and executing model risk management activities consistent with framework, best-practice and regulatory guidance.
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Compliance requirements and guidelines for DMH, DPH, OSHA, NFPA, IBC, MWRA / EPA, and other regulatory agencies not specifically listed. The Director of Facilities Maintenance is responsible for compliance inspections and adheres to all safety, life safety, and equipment management programs as required by the Joint Commission and other applicable regulatory agencies.
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regulatory job Title: travel nurse Company: Next Move in Waltham, MA
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