- Genmab (Plainsboro, NJ)
- …Drug Supply Operations & System team and our cross-functional stakeholders.Together with Global Clinical Drug Supply Operations & Systems team the three teams ... to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Genmab (Plainsboro, NJ)
- …as Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project/Trial ManagementObtain Project/Trial specific information to ... initiate drug supply strategic planning and execution, and maintain information on changing clinical development planIdentify risks for delays for… more
- Genmab (NJ)
- …and the drug development processSignificant experience leading data management activities in clinical trials; advanced use of data management systems ; advanced ... Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …engagements and develops and executes strategies to identify and fulfil complex information needs company-wide using advanced clinical informatics tools and ... techniques. This role requires a deep understanding of both clinical workflows and information technology. Relationships This position reports to the ED/SD of … more
- Genmab (Plainsboro, NJ)
- …with the Global Clinical Drug Supply Planning team. Together with the Global Clinical Drug Supply Systems team, these groups form the Global Clinical ... to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply… 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...protocol(s) and program Provide protocol level scientific review of information to support the development and updates for regulatory… more
- Merck & Co. (North Wales, PA)
- …Experience and Skills: 5+ years prior experience in Enterprise, Business, Information , Systems & Application or Solution Architecture Demonstrated ability ... clinical operations and product quality complaints processes and systems Working Knowledge of Veeva technology productsUnderstanding of regulatory requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a related discipline required and- Master's Degree Life Science or Engineering or Information Systems preferred Experience Qualifications- 7 or More Years At ... feasibility and delivery. The role supports all phases of systems development for global informatics systems , ETL...These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data… more
- Novo Nordisk Inc. (Pearland, TX)
- …(HCPs), stakeholders, and influencers, including but not limited to practices, health systems community health centers, HCPs and other stakeholders in a given ... geography. Utilizing approved clinical resources to support provider efforts to deliver appropriate...appropriate care for patients. Our goal is to provide information as a trusted advisor in care for chronic… 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
- Merck & Co. (Lower Gwynedd, PA)
- …and inclusive mindset Preferred Experience & Skills Background in biostatistics, and/or information management systems is desirableWorking knowledge of AI coding ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Insmed Incorporated (New York, NY)
- …candidate has strong related experience.Other Pharmaceutical experience - Medical Information , Medical Strategy, Clinical management/trial experience and 2 ... therapeutic areas. Engages appropriately in scientific exchanges around product information , disease education, and research ideas/activities with physicians and… more
- Merck & Co. (North Wales, PA)
- …US Regional Director of Medical Affairs (RDMA) (where applicable), US Global Clinical Trial Organization, Global Medical and Scientific Affairs (GMSA) TA leads, and ... prioritized USMA Field strategy and implementation goalsActively participates in bi-directional information exchange and sharing of best practices across the various… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This ... requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Merck & Co. (Rahway, NJ)
- …Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid ... understanding of how countries' medical systems and standards of care need to change to...relevant members to the Product Development sub-teams (Value Evidence, Clinical , Commercial, Publications and Label teams)Aligns medical plans and… more
- Merck & Co. (Rahway, NJ)
- …clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling.Strategizing and executing ... team in the role of Director. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position will be responsible for providing support to implement and maintain computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing ... life cycle management, Quality events, remediation and improvement efforts of computerized systems for equipment, systems and processes in support of… 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
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