- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. - Cross-functional and Global Team ... quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and...merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position will support continuous process improvement initiatives, support the annual Global Quality Strategy Plan for R&D PV QA and track business ... R&D PV QA organizational strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …such as NGS, IHC, PCR requiredTechnical and operational understanding of the IVD Development Process and an understanding of how diagnostic development ... in clinical biomarkers or clinical trial operationsUnderstanding of the IVD Development Process , with direct experience with Companion Diagnostics implementation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the ... teams on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and...merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President, Global Data Management & Standards (GDMS) is responsible for ensuring that all clinical data management products and ... services are effectively delivered with high quality to meet the needs of our... to meet the needs of our Research & Development organization's portfolio. - The scope includes project and… more
- Eisai, Inc (Raleigh, NC)
- …(rfXcel).Provide support and guidance for serialization business processes.Support the qualification process for new integrations with the Global Serialization ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Eisai, Inc (Nutley, NJ)
- …markets. Lead economic assessments and value computations for ADF portfolio at the global level. Lead real world evidence (RWE) development programs in support ... and oncology, with a strong emphasis on research and development . Our history includes the development of...is your profile, we want to hear from you.Director, Global RWE & Data Science sought by a pharmaceutical… more
- Notified (Columbus, OH)
- …activities for new sales leads for assigned business services following the sales process from beginning to end while supporting corporate and departmental goals and ... story narrative for clients Support sales activities such as RFPs and the development of their responses, proposal development and delivery of proposal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with other cross-functional leaders.- Contribute to Clinical Development initiatives, global education, and process development projects, as required. ... CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and...serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP development ,… more
- Merck & Co. (Rahway, NJ)
- …decision-making through validated data sources, including SAP, AERA, and Power BI.Act as the Global Process Owner for Procurement in SAP, responsible for the ... culture of continuous improvement. This role is pivotal in driving procurement process enhancements, ensuring global system efficiency, and delivering measurable… more
- Merck & Co. (Rahway, NJ)
- …implementation of new business platforms to support digital strategies, process development activities, support compliance investigations/change management, ... of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial… more
- Merck & Co. (Rahway, NJ)
- …with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX)Extensive experience with process - and impurity-related residual assay development using molecular biology ... collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Research & Development Division is… more
- Merck & Co. (Rahway, NJ)
- …GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development expertise, equipment ... , Regulatory Affairs, Engineering, and Analytical will be required to ensure effective process development in support of clinical development .- -The … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: MCAAS Finance Leadership Development Program Finance at our Company is committed to developing future leaders through its ... Finance Leadership Development Program (FLDP). Individuals are provided with an entry...Finance by leveraging data analytics and understanding implications on global healthcare systems. Audit assignments are unique to each… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Merck & Co. (North Wales, PA)
- …the entire product lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and ... data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability… more
- Merck & Co. (Rahway, NJ)
- … network. -You will work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are ... degree with a minimum of 3 years of relevant experience in microbiological/analytical development or quality controlKnowledge in the technical aspects and prior… more
- Tris Pharma (Monmouth Junction, NJ)
- …improvement of Good Clinical Practices (GCPs). The role partners with Clinical Development , Clinical Operations, Medical Affairs and R&D Quality Assurance to ... develop and implement quality strategies that align with Tris Development goals and objectives.ESSENTIAL FUNCTIONSEstablish and maintain the GCP QA programs,… more
