• Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and reporting… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    data review tools including listings, patient profiles and other documents to enhance data quality efforts. He/she will serve as the CS primary point of ... contact and advisor to cross-functional partners for data quality processes, enhancements and workstreams (eg...especially for CRF design at the disease and study level. Data Safety Monitoring Board (DSMB): Clinical Science… more
    HireLifeScience (03/19/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    Safety Management Plans. Directs the compilation and interpretation of safety data for reporting purposes, including marketing applications to regulatory ... to ensure compliance with company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation and… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group within the Chemical Engineering Research & Development ... job that provides a high degree of technical and management responsibility. -The Director - Automation Leader position will report to the Senior Director ,… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions,...maximize your potential with us? The Position The Associate Director , Case Management & Training will have full responsibility… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.- Coordinate ... areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionPosition Description: Director , Clinical Literature MonitoringThe Director is responsible for the management and oversight of the day-to-day ... screening of literature on company products to support pharmacovigilance and drug safety and for use in the Product Literature Database.-Responsibilities but are not… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and ... operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Millsboro, DE)
    Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... accountable for the full technology stack across all aspects of Operations, Supply, Quality and Business support at the Millsboro site. The Site Digital Technology… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …of epidemiology approach, provide methodological leadership, identify and validate external data sources for safety related Epidemiology needs.Guide organization ... The CSPV epidemiology group aims to provide strategy leadership in safety signal detection and evaluation, risk management, and post-marketing epidemiological … more
    HireLifeScience (03/07/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... values that can meet business objectives. Relationships This position reports to Director of Business Applications in Information Technology and directly manages a… more
    HireLifeScience (03/06/24)
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  • Insmed Incorporated (San Diego, CA)
    …(CSR) to ensure all studies are delivered on time, within budget and with high- quality data . Leads the cross-functional Clinical Study Team (CST), CRAs, CTAs, to ... training materials, pharmacy manual.Approve action plans to address protocol compliance, safety , data , and administrative issues with investigationalArrange and… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for… more
    HireLifeScience (03/02/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....digital communication and technology trends. Relationships Reports to a Director level position in Medical Information and has a… more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the drug project; Leads the planning and analysis of integrated efficacy and safety data ; Review the relevant sections of the electronic common technical ... leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …health authority requirements; with Quality Assurance to guarantee subject safety and privacy and data integrity. Additional Study-Related Activities: ... Mgmt. & Data Ops. for statistical support and data capturing; with Clinical Safety and Pharmacovigilance for safety endpoint definition and adverse… more
    HireLifeScience (03/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    data to support understanding of sales performance Continuously reviews and evaluates the quality of data and new data sources used in analyses, ... while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide… more
    HireLifeScience (02/03/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Phase 2 Studies: Provides the strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/ data during study conduct, Provides and documents oversight of… more
    HireLifeScience (02/23/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
    HireLifeScience (03/06/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
    HireLifeScience (02/23/24)
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