• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and teams)Support regional representatives in collecting, analyzing, and synthesizing key regulatory intelligence in a systematic mannerEstablishes a database ... Policy activities in one or more regions (USA required), incl. maintaining a database of regulatory intelligence and coordinating engagement with industry trade… more
    HireLifeScience (02/23/24)
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  • Merck & Co. (Rahway, NJ)
    …functions Maintains personal awareness of developments in the fields of medical information , regulatory policy, adverse event reporting, information storage ... Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and interests from the world's… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …requirementsMaintains expertise in developments in the fields of medical information , regulatory policy, adverse event reporting,Identifies and utilize ... Description: Director, Clinical Literature MonitoringThe Director is responsible for the management and oversight of the day-to-day operations of the clinical… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacovigilance, Portfolio Management , Predictive Modeling, Quantitative Research, Regulatory ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsServing… more
    HireLifeScience (03/05/24)
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  • Merck & Co. (Durham, NC)
    …to function in a team-based empowered culture - Seeks ideas and information on how to improve customer service involving internal and external customersApplies ... equipment, completing validation protocols, documenting work using a computerized maintenance management system and other duties as requested by the Utility… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Relationships This position reports to Director of Business Applications in Information Technology and directly manages a staff of professionals, supplemented by ... direction in all aspects of AEM development including application architecture, database design, UI design, testing methods, and validation requirements Establish… more
    HireLifeScience (03/06/24)
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  • Merck & Co. (North Wales, PA)
    …position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across our ... patterns and disease progression, answer clinical development questions, and support regulatory submissions. - In this role, the associate principal statistical… more
    HireLifeScience (03/08/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight of information ... of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.Must have a… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Durham, NC)
    …empowered culture but perform successfully as an individual. Seeks ideas and information on how to improve customer service involving internal and external ... This individual will partner with Quality Operations (QO) Lab Plant Engineering Management as well as the respective lab managers to provide equipment services… more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …functional areas to adopt a data mindset that enables better data, for faster database locks and reduction of database unlocks. This position requires a strong ... working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry standards, and technical skills in working with… more
    HireLifeScience (03/07/24)
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  • Merck & Co. (Durham, NC)
    …multi-stage refrigeration systems) Required Experience and f amiliarity of regulatory requirements in accordance with GMP manufacturing operations Preferred ... the biopharmaceutical fieldExperience with GMP compliant calibration and/or maintenance database systems.Knowledge of SAP and DeltaV and Procal.Physical Requirements:… more
    HireLifeScience (03/09/24)
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  • Merck & Co. (Durham, NC)
    …empowered culture but perform successfully as an individual. Seeks ideas and information on how to improve customer service involving internal and external ... This individual will partner with Quality Operations (QO) Lab Plant Engineering Management as well as the respective lab managers to provide equipment services… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (North Wales, PA)
    …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the ... set up and design during study start up (eg, database set up)Lead medical monitoring team in review and interpretation of clinical data/medical protocol-deviations… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity… more
    HireLifeScience (01/25/24)
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  • Merck & Co. (San Diego, CA)
    …including working as part of a matrixed team to address regulatory agency questions and/or feedbackBackground in inflammatory diseases (eg autoimmune diseases, ... status, or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity Employment laws,… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills ... in database and research tools.ResponsibilitiesSupport the Head Global QA strategy...relevant activities including Business Plan, QQR, team building and management review.Involve and attend the Global QA relevant meeting… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …into different functions of GMP QA Department such as Audit, Quality Management System, Pharma Product, External Supplier Management and Strategical Operations ... potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance, internal/supplier auditing, or customer focus activitiesPerforming the… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …existing systems, this role provides knowledge, testing, documentation, Service Level management reporting. This role will liaison with operations and other support ... project or service level agreement timelines and cost estimates Gathers and compiles information on vendor performance and identifies areas that can be improved in… more
    HireLifeScience (01/25/24)
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