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Practical knowledge of pharmaceutical marketing that includes FDA regulatory and legal environment and HCC regulations is required. Practical knowledge of pharmaceutical marketing that includes FDA regulatory and legal environment and HCC regulations is required.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Pdf) following FDA/CDISC or sponsor guidelines. Create electronic submission package to FDA, e.g., define. pdf following FDA guidelines with minimum supervision. ClinChoice is a global CRO supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide.
Full-timeRemoteExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Practical knowledge of pharmaceutical marketing that includes FDA regulatory and legal environment, reimbursement, managed markets and all channels. Practical knowledge of pharmaceutical marketing that includes FDA regulatory and legal environment, reimbursement, managed markets and all channels.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Keywords: GMP, GLP, GXP, GCP, batch record management, batch record review, full-process manufacturing, cell therapy, deviations, junior role, maintenance, calibration, FDA, EMA, biopharmaceuticals, quality assurance, QA.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Familiarity with 21 CFR Part 11 and other FDA regulatory requirements. Participate in client and FDA system audits as required. Knowledge of Azure DevOps (TFS), MTM and Sharepoint preferred.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Experience in Control Systems (Emerson DeltaV, Allen Bradley, Foxboro, Siemens, Honeywell). Experience with SCADA, MES, and database systems, or computer system validation are considered a plus. Design and develop manufacturing control systems in support of process operations.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Knowledge of treatment guidelines, clinical research processes, FDA regulations, and Officer of Inspector General (OIG) guidelines preferred. Direct the development and execution of US medical science liaison (MSL) strategies as well as oversight of MSL territory plans.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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B) Global Regulatory Affairs and Clinical Safety : Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures for interacting with health agencies (e.g. FDA); understand key elements in pharmacovigilance, drug safety monitoring, signal detection and processing of adverse reports After a successful first year, the Physician Scientist will be equipped to assume a leading role in the team with additional responsibilities and interactions.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. We are hiring a Shipping Clerk.
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Assist in preparing for and responding to all state and CFPB/FHA/VA/USDA examinations. Employee Matching Gifts Program: We will match monetary employee donations to eligible non-profit organizations, dollar-for-dollar, up to $1,000 per employee.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Knowledge of FDA regulations, drug development and PM processes. Independently manages Biometrics project teams from study start-up through study closeout; departments include but not limited to, Data Management, Biostatistics, Statistical Programming, and Medical Writing.
Full-timeRemoteExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs, Computational Biology, Drug Development, Drug Discovery Process, FDA Regulations, Leadership, Mathematics, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacovigilance, Portfolio Management, Predictive Modeling, Quantitative Research, Regulatory Documents, Statistics, Strategic Data Analysis, Strategic Planning, Therapeutics.
$200,200 - $315,100 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago
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