• Merck & Co. (Rahway, NJ)
    Job DescriptionPosition Description: Director , Clinical Literature MonitoringThe Director is responsible for the management and oversight of the day-to-day ... operations of the clinical literature information center, which is responsible for the...the latest technology in information storage and retrieval systems.The Director works cross-functionally and uses experiences to assess the… more
    HireLifeScience (03/22/24)
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  • 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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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
    HireLifeScience (03/21/24)
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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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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
    HireLifeScience (03/15/24)
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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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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
    HireLifeScience (03/09/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies… more
    HireLifeScience (03/01/24)
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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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  • 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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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety… more
    HireLifeScience (03/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....to maximize engagement and talent retention. Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
    HireLifeScience (03/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …of this position are the plan, design, and conductance of early development clinical studies; the preparation of regulatory documents to file IND and report studies; ... and the representation of the specialty medicine (SM) clinical development (CD) function on study and project teams....Affairs to align study with health authority requirements; with Quality Assurance to guarantee subject safety and privacy and… more
    HireLifeScience (03/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
    HireLifeScience (03/27/24)
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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 ... your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the… more
    HireLifeScience (02/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....to maximize engagement and talent retention. Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
    HireLifeScience (03/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …research areas centered around rare diseases and immune disorders. Summary The Director of Clinical Bioanalysis has the responsibility of providing strategic ... bioanalytical leadership for all phases of clinical development for small molecule and biological therapeutic programs and participate in strategy implementation.… more
    HireLifeScience (01/08/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliancerelated to Good Pharmacovigilance Practices (GVP) and other related… 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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