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Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs.
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Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
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Reports adverse drug reactions and submits the appropriate documentation to the FDA, NCI and IRB. The Clinical Research Nurse Specialist manages post-transplant patients and contributes to multiple studies within the section of Transplant Surgery under supervision of the Principal Investigator (PI), Dr. Piotr Witkowski.
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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. Serve as primary clinical point of contact with the US FDA and other foreign regulators and notified bodies, and act as Clinical Lead for complex FDA negotiations leading to successful new product clearance and approvals for the Biomarker program.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Ensure compliance with relevant quality standards, regulations, and safety protocols, including ISO, FDA, OSHA, and cGMP requirements. Knowledge of quality management systems (QMS), statistical process control (SPC), and quality assurance principles.
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Prepare and submit MDR reports to FDA. Process complaint files from initiation to closure. Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. That's how we tackle rare disease. U.S. based e mployee s may be eligible for s hort -t erm and/or l ong- t erm incentiv e s. By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.
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Perform and document FDA and SPD testing on assigned products. Perform and document FDA and SPD testing on assigned products. Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions.
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Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required. To be considered you are required to have 8+ years of relevant experience, which includes 4+ years working as a Medical Science Liaison within the Oncology/ Hematology field or a combination of experience working within Oncology/ Hematology (lymphoma and/or multiple myeloma is preferred.
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Selection of suitable plasmapheresis donors by performing physical examinations and taking medical histories on all donors through the use of FDA approved Standard Operating Procedure (SOP) Manual, current State and Federal guidelines, OSHA, CLIA, CGMP, all internal company procedures and personal education and experience.
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Troubleshoot import delays and ensure timely and accurate response to Broker Requests for Information for shipments detained during clearance through US Customs, FDA, USDA and other government agencies.
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In support of FDA approved products, work within the Medical Science Liaison team’s objectives. · Provide field-based scientific exchange and communication of FDA approved and pipeline products.
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Robust knowledge of Aramark policies, regulatory safety procedures and requirements including OSHA, FRA, FDA, USDA, CDC, DOT, Amtrak Public Health, state, country, and local agencies to ensure training and operational compliance.
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While prior knowledge is always a plus, we are happy to provide thorough training on OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration), and FSMA (Food Safety Modernization Act) regulations.
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Qualifications & Requirements:Minimum of 8+ years of experience in Operations/plant management, (FDA, USDA, HACCP, Excellent people management skills, with the ability to motivate, develop, and mentor employees at all levels of the organization.
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fda job in Oak Park, IL
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