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Author and update internal and external documentation, and formally initiate and deliver requirements and documentation. Help to determine path forward to maintain alignment from Certified applications to business processes.
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OReview design development documents, budget and schedule for funded projects and author and issue design review comments. oManage specialty areas including budget revisions, closeout, review comments, cost data publication, monthly reports and commissioning.
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Author, review, and update CMC submission components (Module 1, 2.3, and 3) to support post-approval supplements, annual reports, registration renewals, and responses to health authority queries.
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Author and review Equipment Requirements Specifications (ERS). Author and review new and existing Standard Operating Procedures (SOPs). An Equipment Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery in the Boston, MA area.
$65.79 an hourFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Perform data analysis and author/ review method SOP, assay development summary and report. Scientific training and hands-on experience with various cell-based and molecular assays, including but not limited to 2D and /3D cell culture, cell-based potency assay, ELISA, western, qPCR, RT-qPCR, and DNA/RNA/protein extraction from cells and animal (including NHP) tissues.
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Ability to compile data results and author commentary on industry studies is a plus. Experience with ANY of the following technologies: SQL Server Reporting Services (SSRS), SSIS Reporting, Power BI, Dynamics CRM, Dynamics GP, SharePoint, Excel, Power Query, Power Pivot.
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The position will provide opportunities to conduct independent research and co-author papers. Responsibilities will include bacterial culturing and plant cultivation, bacterial genetic transformations and screens, running liquid chromatography mass spectrometry samples, ordering supplies, and assisting with general instrument maintenance and lab upkeep.
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First author publications at peer-reviewed AI conferences (e.g., NeurIPS, CVPR, ICML, ICLR, ICCV, and ACL) Adapt standard machine learning methods to best exploit modern parallel environments (e.g. distributed clusters, multicore SMP, GPU, and cloud training infrastructure found.
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Able to author policy forms, review State regulations, and create policy wording for issuance and eventual submission. We have assignments available to help our insurance carrier or MGA clients in Compliance Specialist - Rate Filing positions.
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As the Literacy Specialist, you will be the lead author of this program. As the Literacy Specialist, you will be the lead author of this program. Founded in 2007, we partner with governments to provide integrated school management, teacher professional development, instructional design innovation, technological system support, child-centered classroom practice, and parent engagement.
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Author and execute protocols and technical reports summarizing key findings and results. Data analysis (software: e.g. JMP, Minitab) Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization or qualification in a GMP environment.
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Update, author, and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap Assessments. Demonstrate a sound understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing/packaging processes.
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