• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …centered around rare diseases and immune disorders.Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Associate Director , Clinical Supply Operations (CSO) within Global Clinical Supply (GCS) is responsible for supporting launch and ... processes, as well as business continuity.Key responsibilities of the Associate Director , Clinical Supply Operations include:Supporting the implementation and… more
    HireLifeScience (03/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the... trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role… more
    HireLifeScience (03/11/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …disorders. Summary This position will be the Head of Data Review Excellence in Clinical Science, reporting to the VP, Global Head of Clinical Science. He/she ... will be accountable for building and establishing the clinical data review standards across early and late-stage asset...listings, patient profiles and other documents to enhance data quality efforts. He/she will serve as the CS primary… more
    HireLifeScience (03/19/24)
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  • 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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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …relationships with external partners relevant to the design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg ... with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg,… more
    HireLifeScience (03/27/24)
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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 ... Role is responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through clinical study report… more
    HireLifeScience (03/12/24)
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  • Eisai, Inc (NJ)
    …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead...in supplier oversight and governance meetings and lead processes improvement initiatives as required.Report to Director on… more
    HireLifeScience (02/01/24)
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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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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement ...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality more
    HireLifeScience (02/24/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma. Legend Biotech is seeking Director , Quality Assurance as part of the...This role will also be responsible for trending of quality operations metrics and developing continuous improvement more
    HireLifeScience (01/31/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to influence and effectively drive organizational change and continuous innovation and improvement . This role will assist in driving the connection between the ... identification of Critical to Quality data and processes, the Risk Assessment, and Data...unlocks. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications,… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
    HireLifeScience (03/16/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , HEOR leads the execution of HEOR strategy and evidence development ... demonstrating the value of Insmed's product(s) for intended indication(s). The Director collaborates with stakeholders across the company including market access,… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… more
    HireLifeScience (02/21/24)
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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 ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
    HireLifeScience (03/02/24)
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  • Merck & Co. (Rahway, NJ)
    …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... responsibility. The Senior Specialist - Process/Facility Engineering position will report to the Director , Engineering and will be a member of the EF Team at the… more
    HireLifeScience (03/24/24)
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  • Eisai, Inc (Nutley, NJ)
    …training programs as well as evaluation of training outcomes (effectiveness and quality ) for continuous improvement . Define, monitor, and report on training ... training, advanced product training, improved selling skills, disease state knowledge, clinical and business acumen application of the Eisai Selling model and… more
    HireLifeScience (02/21/24)
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  • Merck & Co. (Rahway, NJ)
    …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... Development and Maintenance (EDM) Facility Specialist Engineering position will report to the Director , Engineering and will be a member of the EF Team at the… more
    HireLifeScience (03/15/24)
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  • Merck & Co. (Rahway, NJ)
    …The Associate Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production,… more
    HireLifeScience (03/23/24)
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