- 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 ... development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial-related, GxP, Compliance, etc.) across the US and Canada… more
- Genmab (Plainsboro, NJ)
- …role in the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual ... & System team and our cross-functional stakeholders.Together with Global Clinical Drug Supply Operations & Systems team the three teams make up the Global … more
- Genmab (Plainsboro, NJ)
- …multi-disciplinary teams.Lead and oversee development and implementation of clinical pharmacology and quantitative sciences systems /processes and "best ... team covers a broad spectrum of capabilities, including Quantitative Systems Pharmacology, Quantitative Translational Pharmacology, Pharmacometrics and Clinical … more
- Genmab (Plainsboro, NJ)
- … Drug Supply:Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation area including implementation of new regulations ... & System team and our cross-functional stakeholders.Together with Global Clinical Drug Supply Operations & Systems team the three teams make up the Global … more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Clinical Research Scientist (CRS) will support and work predominately with the ... Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols...Brochures)Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategiesProvide scientific support… more
- Merck & Co. (North Wales, PA)
- …Outcomes Research, Clinical Development, Global Human Health (GHH), EDFMA Health Systems , EDFMA of Oncology TA teams, Global Medical & Value Capabilities (GMVC), ... primary role of the US Executive Director, Field Medical Affairs, Health Systems Oncology (EDFMA-HSO) is the leadership, management, and accountability of a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …manage relationships with external partners relevant to the strategy, design & implementation of clinical trials improvement/innovation projects for NACD & Novo ... positively with multiple internal stakeholders relevant to the strategy, design & implementation of clinical trials improvement/innovation projects for NACD &… more
- Aequor (South San Francisco, CA)
- …the Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high-quality clinical trial data insights and ... and improvement of technology and analysis solutions necessary for RBQM implementation within Roche/Genentech, including in-house systems and potential external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Integration Methodology. Provide informatics solution architecture expertise to all systems implementation projects. Performs regular solution/code reviews with ... IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and execution of ... and regional directors and associate directors. The Executive Director, Value & Implementation (referred to as EDMA) engages with global scientific leaders and key… more
- Novo Nordisk Inc. (Sacramento, CA)
- …The EDCS must achieve sales goals by utilizing a patient-centric and clinical approach to engaging their customers and promoting Novo Nordisk's portfolio of ... assess, create and maintain advocacy of customers aligned to company, brand and clinical goals; the EDCS develops local strategies and executes local tactical plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coding process.Working knowledge of MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding tools is a preferred ... of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and EU.- Special Projects/Change Management - Accountable for the development and implementation of new processes, procedures and/or systems to improve ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...- Assist the senior Finance staff with recommendations and implementation on new and existing systems utilized… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide technical recommendations for Changes and process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change ... vendors. This position is also responsible for the delivery of systems , configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety… more
- Merck & Co. (Rahway, NJ)
- …company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and … more
- Merck & Co. (Rahway, NJ)
- …support for processing equipment in the FLEx Oral Solid Dosage (OSD) area for clinical drug product manufacturing, located in Rahway NJ. The FLEx OSD area supports ... the formulation and manufacturing of oral products for intended for critical clinical trials.-The area is inclusive of the following processes: milling, blending,… more
- 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 ... ready to make a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is responsible for providing strategic direction, planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and ... functional cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview… more
- Merck & Co. (Rahway, NJ)
- …-As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that guide solution decisions ... solutions.- You will focus on analyzing, designing, and developing solutions and implementation plans based on a current versus future state solution and reference… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for facilities engineering support, design, and implementation for mechanical systems and equipment, and work order ... management for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of… more
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