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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The legal assistant will provide support in all aspects of file handling for senior attorneys and paralegals. RAM Law, an established plaintiff’s personal injury law firm, seeks a full-time legal assistant to join its fast-paced and collaborative Somerville office team.
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Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA.
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Proficiency in Microsoft Office (Excel, Word, PowerPoint), Power BI, and electronic file management. Additionally, this role involves providing technical support for Treaty Property Reinsurance contracts, including Property Cat and Retro Cat, Per Risk Excess of Loss programs, Quota Share programs, and Crop-Hail programs.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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Perform tasks such as file management, transcribing, and data entry in Excel. Provide administrative assistance to the assigned lab Manager. Perform tasks such as file management, transcribing, and data entry in Excel.
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Job Description Global Property and Casualty Provider seeks an experienced Scrum Master to play a crucial role in the roll out and ongoing maintenance of the Guidewire InsuranceSuite to enhance the company’s core business operations.
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Hour commensurate with experienceScope of JobOur client is a technical professional organization dedicated to advancing technology for the benefit of humanity and we are seeking a Senior Scrum Master to help with their transformation from a waterfall to a product-oriented delivery model.
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Understanding of master data management and maintenance. Seeking a candidate to coordinate clean up of master data to prepare for SAP implementation. Appreciates master data and the rigor that goes with best practices.
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Position Overview:The Clinical Trial Manager of Clinical Operations is responsible for supporting and planning, budgeting, directing, and evaluating clinical trials under GCP and ICH regulations.
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Whether you are healthy, or have a specific illness, we'll connect you with the right trial. Potentially get paid to access the most cutting edge medicines combating your disease. Whether you are healthy, or have a specific illness, we'll connect you with the right trial.
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Review Pilot/Trial Batch Cards submitted by Manufacturing Site. Write Bulk Holding Protocols and manage approval process as required. It's the ripple effect that changes and improves everything for your family, your community, and the world.
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RESPONSIBILITIES:Work one-on-one with the learner in their home and/or community to deliver DTT (Discrete Trial Training) and NET (Naturalistic Environment Training) on measurable goals set by the FBA (Functional Behavior Assessment.
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The Bucks IU Behavior Analysts have the primary responsibility of providing high quality services in the areas of functional behavioral assessment, positive behavior support, verbal behavior, discrete trial, data collection and data analysis, classroom consultation, and staff training.
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The paralegal will assist the attorney(s) by providing clerical and research support services including document preparation and review; interviewing clients and witnesses; research, investigations, fact checking, and trial preparation.
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trial file jobs Title: trial master in Somerset, NJ
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