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100% Remote or onsite in Tampa at candidate's preference Our Fortune 500 pharma client needs a Senior Regulatory Affairs Consultant to support an influx of work around submissions and change controls for their Cell & Gene Therapy products. Contract Length 12 months, with the possibility of extension/conversion Requirements of the Senior Regulatory Affairs Consultant Bache
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We have an excellent job opportunity as an R&D Systems Engineer Our role is expected to last 6 months. Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Our client is looking for t
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of the Quality Engineer Support MRB/NCR activities for assigned products with timely resolution of nonconformities/deviance Provide technical support for manufacturing technical issues and timely resolution Use problem solving/root cause tools and techniques and apply risk based approach to problem solving Requirements of the Quality Engineer Strong working knowledge of no
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Our rapidly growing medical device client needs a Senior Electrical Engineer to join their team. You will design, develop, and commercialize next generation products while working on sustaining initiatives for current line of products. We can facilitate w2 and corp to corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental
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of the BA Support Sales and Marketing strategy to build market share Analyze and model financials to support department objectives Manage product life cycle from end to end, including sales reporting and market research Support development and administration of generic sales reporting/analytics tool Requirements of the BA Bachelor's degree in Business, Marketing, Analytics
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of the Clinical Trial Manager Provide oversight for CRO's and monitoring activities Work on a high visibility and fast paced phase 2/3 vaccine study Work within a fast paced environment and adapt quickly to changes Requirements of the Clinical Trial Manager Bachelor's degree, scientific field preferred 8+ years of clinical research experience 5+ years of strong senior CRA
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of the R&D Engineer Collaborate with R&D team to design and develop new generation catheter product Manage and develop catheter related risk management file deliverables Provide technical support to operation in developing and executing acceptance test protocols Perform and document comprehensive analysis and root cause determination of product failures Requirements of the
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of the Engineering Consultant Act as process technical SME for assigned manufacturing area Collaborate develop, review, and approve PFDs, P&IDS, material, and/or energy balances Design process equipment, material and personnel flows, process utilities, waste streams Ensure design compliance with internal client quality and design standards Requirements of the Engineering C
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of the Pharma Consultant Provide pharmacology expertise in support of drug R&D programs within dermatology, neurology, hepatology, and GI Research in vitro and in vivo animal disease models to investigate mechanism of actions, assess efficacy, and/or select lead formulation Review scientific literature and author technical documents summarizing information from literature
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Remote position with up to 10% travel (including trips to Boston to spend time with team and site visits) Our Fortune 500 healthcare client is seeking a Senior Clinical Program & Portfolio Manager to be the leader of a portfolio of studies. We can facilitate w2 and corp to corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, D
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of the Interim Director Provide strategic direction to drive risk based quality execution of portfolio at EU regional, country, and site level Provide quality/strategic advice to Clinical Operations Management group globally related to GCP compliance of COM processes and their continuous improvements Drive quality oversight of country level Key Quality Indicators (KQIs) an
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of the Regulatory Consultant Work with teams on CDx plans and documentation Evaluate instances and determine/advise on whether IDE is needed Confirm US FDA regulations Work cross functionally with diagnostic partner and client team Assist and advise with strategy, execution, and tasks for US CDx Requirements of the Regulatory Consultant US CDx regulatory expertise Demonstr
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of the R&D Documentation Specialist Lead the creation of documents, drawings, and specs to meet system requirements Act as document control specialist to process all documents Create documents, drawings, and specs for medical device Provide Regulatory team with technical input and concise documentation Review and finalize completed informational sections of document format
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of the CTA Support day to day operational activities of assigned trials Ensure study objectives and timelines are met with quality, in compliance with SOPs and regulatory guidelines Maintain clinical trial files, project processes, tracking systems, and other utilized study or departmental systems Coordinate project team and departmental meetings, including associated docu
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of the Compliance Analyst Ensure consistency and compliance with enterprise standards and relevant regulations Support compliance operations, logistics vendors, and marketing partners by analyzing data and providing reports Review and validate advisory board executive summaries and pull through documentation Requirements of theCompliance Analyst Demonstrated experience in
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