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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
$117ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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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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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
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Oversees the activities of the Clinical Staff, which is composed of Donor Management Coordinators and Donor Referral Responders regarding all activities related to organ procurement activities, which includes but is not limited to: potential donor referral response, consent practices/procedures, clinical donor management procedures, allocation/preservation of organs, procurement procedures, organ placement practices, and regulatory agency matters.
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Knowledge of regulatory and compliance requirements for clinical research, including but not limited to, US CFR, ICH, GCP, GDP, EU/UK GDPR. Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF.
$138,500 - $153,100 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Minimum 2-4 years of clinical laboratory testing experience is required. OPEN TO EITHER Medical Lab Technician [2-year MLT degree] or Medical Lab Scientist / Medical Technologist (4-year BS)Looking for a generalist [coagulation, hematology, urinalysis, etc.
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This position works under limited supervision of a BMET Lead or Clinical Engineer, conducting work, providing records, and maintaining a database of scheduled maintenance, corrective maintenance, and safety testing in accordance with manufacturer, regulatory, and department guidelines.
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Board Certified Behavior Analyst (BCBA®) (strongly preferred), Licensed Clinical Psychologist, MFT, MSW, with current licensure in good standing with regulatory board and strong background in ABA.
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Participates in the coordination and completion of multidisciplinary efforts in regard to regulatory preparedness and completion of applications (e.g. Hospital Accreditation and Licensure, CMS Database Forms, ICM completion, measurement of success data, DPH/DOH or CMS corrective action plans, and clinical charter teams.
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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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Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP's, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
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