- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation , data delivery and reporting. Will represent ... of clinical research standards and GCP.Develop operational strategies for implementation of clinical studies regionally/globally in conjunction with project… more
- Merck & Co. (Rahway, NJ)
- …the development, analytical validation, and testing of histopathology-based assays for clinical implementation and advancing digital pathology within our ... knowledge of the drug development process and translational medicine.Experience in clinical biomarker development or managing the implementation of biomarker… more
- Insmed Incorporated (San Diego, CA)
- … clinical trials. This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, ... Rave. Proven track record of leading EDC system design and implementation for clinical trialsAdvanced proficiency in the broader Medidata Clinical Cloud… more
- Merck & Co. (North Wales, PA)
- …GPAM comprises several distinct groups, including Project Managers in Value & Implementation (which is this job), Development, and CMC; Discovery Portfolio Managers; ... and Administrative Professionals.Position Description/Summary The GPAM Senior Specialist, Value & Implementation Project Manager (VIPM), is a core member of Value &… more
- Merck & Co. (Rahway, NJ)
- …strategic implementation of `quality by design` principles in assigned clinical trials.The CQOM will develop Risk Assessment and Categorization Tools and Quality ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of...management and inspection management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the ... key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments… more
- Eisai, Inc (Nutley, NJ)
- …Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical ... your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality...you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery… more
- Eisai, Inc (Nutley, NJ)
- …development, planning, implementation , and oversight of Phase I through IV clinical trial programs and early new product development within the Medical Affairs ... prepare progress updates as needed.Participate in the design strategies, planning and implementation of Phase IV clinical development programs for assigned… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Executive Director Pulmonary Hypertension, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) (referred to as EDMA) is ... for the generation of the global strategic value and implementation plan, its global and regional execution, and the...Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides… more
- Merck & Co. (Rahway, NJ)
- …The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation ... connection and collaboration within and across teams and functions.-The NGB GMP clinical manufacturing building will be a new entirely single-use facility, and this… more
- Merck & Co. (Boston, MA)
- …operations, and biomarker operations teams as they key liaison to enable implementation of precision medicine strategy in clinical trialsContribute to creation ... programs, driving the Precision Medicine objectives in alignment with clinical development plans. Collaborating with Discovery, Translational Medicine and Product… more
- Merck & Co. (Rahway, NJ)
- …and works in close collaboration and alignment with the Value and Implementation lead. Support the Regional Directors Medical Affairs and other medical functions, ... that address asset value proposition, insights from affiliates and regions, and clinical and value evidence gaps. Translate these Goals and Strategies into research,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …commitments, medical access programs.Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through ... QA, Development QA, and PVQA) to address GxP-related issues impacting clinical /medical access programs. Drive necessary change and efficiency through provision of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnerships, largely focused on digital pathology, to support design and implementation of translational pathology plans.- Lead development of the translational ... data generation for assigned assets, with a focus on the design and implementation of translational pathology plans.- Provide expertise to the Daiichi Sankyo Global… more
- Merck & Co. (Rahway, NJ)
- …Affairs Therapeutic Area (GMSA TA) teams to translate Global Value and implementation (V&I) goals into the relevant US country-level goals and priorities. -The ... tactical activities. -Supports ongoing development and mentorship to support implementation of individualized employee development priorities.Develops and effectively manages… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for strategic initiatives and capacity expansion activities at the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner ... of personalized cell therapy production through safe and compliant project implementation in cGMP production environment. The individual will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have ... risk management. Responsibilities Leadership, Direction, and Strategy: - In collaboration with Clinical Development and Clinical Operations as well as other BDM… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization within the Pharmaceutical Sciences and Global Clinical Supply (GCS) global organization. This role is critical in looking ... and compliance requirements.Automation & Digital Technologies ImplementationOversee the selection, implementation , and optimization of inventory management systems (IMS) and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The Executive Director, Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… more
- Merck & Co. (North Wales, PA)
- …given projects; is business savvy and results oriented -Working knowledge of clinical drug development, with relevant experience that informs fluent understanding of ... recommend, contribute to development of conceptual plans for, and lead implementation of, strategic, process, and team improvement and change initiatives… more
