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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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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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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Advise clients on regulatory compliance and risk management issues related to securitization and structured finance. Familiarity with regulatory frameworks and compliance issues in securitization.
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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.
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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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Perform assessments of organizations' fraud detection models, including in alignment with the U.S. Office of Comptroller of Currency Supervisory Guidance on Model Risk Management and other regulatory requirements.
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Responsible for developing the systems, tools, and infrastructure needed for project management core activities, including study start-up activities, coordinating and managing site activation, research staff training, regulatory submissions, event tracking and reporting, deviation and violation tracking and reporting, participant accrual tracking and reporting.
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This position requires a deep understanding of pharmaceutical manufacturing principles, process engineering, and regulatory compliance. Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.
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Collaborate externally with Drug Safety vendors and business partners on case management issues, processes, and timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations.
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Interface with and drive collaboration between the various functional teams: Platform Discovery, Medicinal Chemistry, CMC, Disease Biology/Pharmacology, DMPK/ Preclinical Drug Safety, Regulatory & Medical Affairs and Clinical and with the Leadership Team on program-related matters.
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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). Series 07 - FINRA, Series 24 - FINRA.
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regulatory job in Newton, MA
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