- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global ... process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design… 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
- 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)
- …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
- 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
- American Honda Motor Co Inc (Marysville, OH)
- …leadership experience. People leadership experience. Operation Standard Best Practices. PDDA, Process Quality Control Tables (PQCT's), MQS/FASP, OQ Flow and ... and scheduled manpower reductions.New equipment or procedure introduction to process .Regional or Global study requests for benchmarking, standardization,… 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. (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)
- 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
- 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)
- …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. (Durham, NC)
- …site to include the following: Provides management and leadership for the above-listed Quality Systems to ensure compliance with all global and regulatory ... above-listed Quality Systems and other related initiatives. Supports SOP development and/or approval as needed. Ensures support of regulatory inspections and… 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
- Merck & Co. (Rahway, NJ)
- …expression in mammalian systemsKnowledge of Quality by Design, Process Characterization and Control Strategy development #BPRD #PRD #EligibleforERPEmployees ... providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Merck & Co. (Rahway, NJ)
- …to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. ... method development GMP laboratories, complementary areas of Analytical Research and Development , Biologics Process Research and Development , CMC and… more
