• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical ... for the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on… more
    HireLifeScience (03/01/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …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 activities performed by… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …Labeling Therapeutic Area group is to drive labeling strategy and ensure high- quality and compliant labeling documents, which provide the safe and effective use ... Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:- Developing, maintaining, and implementing Core… more
    HireLifeScience (03/02/24)
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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)
    …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...in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant… more
    HireLifeScience (03/11/24)
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  • Merck & Co. (North Wales, PA)
    Job Description- Role Summary:The Process and Systems Lead Senior Director , Medical Operations (Lead, P&S) is a leadership role within Global Medical and Value ... Medical and Scientific Affairs (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead.-The Lead, P&S is responsible for managing… more
    HireLifeScience (03/22/24)
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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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  • Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... , audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality more
    HireLifeScience (03/27/24)
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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 , ... 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)
    …and Data Management members to ensure timely deployment of high- quality biomarkers analysis on clinical samples.ResponsibilitiesOversee implementation of ... the timely execution of biomarker tests on samples from clinical trials and to perform technical and strategic assessment...strategic assessment of new and innovative biomarker platforms for clinical trial, and to support for clinical more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
    HireLifeScience (03/26/24)
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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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  • 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. This position requires significant understanding… 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 ... this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to… more
    HireLifeScience (02/01/24)
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  • Merck & Co. (Rahway, NJ)
    …management responsibility. -The Director - Automation Leader position will report to the Senior Director , Enabling Facilities, and will be a member of the EF ... Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group within the Chemical Engineering Research & Development… 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 ... Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality...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...on continuous improvement to organizational agility. Manages team of senior managers and professionals within Quality . Hires… more
    HireLifeScience (01/31/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and on the market through appropriate epidemiology studies. This Executive Director , the sub-functional lead for Epidemiology group in Global Medical Safety, ... able to provide essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact… more
    HireLifeScience (03/07/24)
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