- 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 ... research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and… more
- Eisai, Inc (Nutley, NJ)
- …Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical ... and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing skills Experience… more
- Insmed Incorporated (San Diego, CA)
- …role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency ... builds using established standards and efficient processes in the implementation and integration of patient data systems ....Proven track record of leading EDC system design and implementation for clinical trialsAdvanced proficiency in the… 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
- 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. (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 ... Affairs Team (MAT) meetings.Establish and maintain strategic partnerships with Health Systems (HS) by leading RMSD medical account planning initiatives to enhance… more
- Merck & Co. (Rahway, NJ)
- …compliance requirements.Automation & Digital Technologies ImplementationOversee the selection, implementation , and optimization of inventory management systems ... & Technology (DD&T) organization within the Pharmaceutical Sciences and Global Clinical Supply (GCS) global organization. This role is critical in looking… 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 ... payers, policymakers, health technology assessment (HTA)/ reimbursement agencies, and health systems globally. The ability to successfully participate in and lead… more
- Merck & Co. (Rahway, NJ)
- …with reduced error rates - A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize ... a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance of dCMC Regulatory A… more
- Merck & Co. (North Wales, PA)
- …These projects can be cross divisional and relate to optimizing PM capabilities, systems , and operations (e,g., leading efforts to improve planning systems ... given projects; is business savvy and results oriented -Working knowledge of clinical drug development, with relevant experience that informs fluent understanding of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe Facility Engineer will be responsible for ensuring equipment/ systems required to support an expanding Cell Therapy facility is appropriately ... lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require technical expertise and troubleshooting ability… 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 the development and … more
- Merck & Co. (Rahway, NJ)
- …and implementing novel quantitative approaches (for eg, comparator modeling, clinical trial simulations,- quantitative system pharmacology (QSP) and disease ... methods) that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go… more
- BioAgilytix (Durham, NC)
- …to add/move/change user accounts and workstations; addresses issues with corporate systems such as printers, phones, and audio-visual (AV) equipment; and supports ... related to the overall corporate infrastructure and validated computerized systems .Essential Responsibilities Prioritize and respond to end user service requests… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs. ... position also supports the management of the WO development and implementation .Supports packaging design and patient kit supply preparation, label generations and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical, advanced Excel ... of various materials including (but not limited to) critical supplies, clinical materials, components and consumables.Participate in regular Site Supply Chain /… more
- Merck & Co. (Irving, TX)
- …addressing line non-conformances, Root Cause.investigation and Corrective Action implementation skills preferred and maintain line efficiencies on Target.Responsible ... Office products, Excel knowledge required. Experience with enterprise resource planning (ERP) systems is required; two years' experience with SAP is a plus. Must… more
- Eisai, Inc (Nutley, NJ)
- …the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp ... leadership skillsDemonstrated analytical and problem-solving skillsExperience in development and implementation of brand plansStrong communication and presentation skillsUnderstanding of… more
