- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead the CRO and vendor ... study team in end-to end delivery of the clinical trial with consistency, quality and per...standards and timelines and that quality of data is suitable for regulatory submission. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and understanding of CMC principles, strategies, and processes: Understand regulatory compliance/requirements of manufacturing clinical and commercialization ... involvement with all phases of project management Work with operations and quality groups to maintain products at a high level of performance/compliance Collaborate… more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines… more
- Merck & Co. (Rahway, NJ)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential... Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... utilities, and facility qualification, process validation, shipping validation, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... of manufacturing investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and identifying trends.Contribute to maintain… more
- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... appropriate identification, evaluation, and management of risks associated with product quality . Build strong relationships with regulatory agencies and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight… more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking QC Analyst I as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Analyst is an exempt level ... QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities… more
- Merck & Co. (Rahway, NJ)
- …project level Position Specific Required Skills and Experience: Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic ... in CDISC SDTM and ADaM standardsSignificant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPHDesigns… more
- Merck & Co. (Rahway, NJ)
- …be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality , Legal, Privacy and Finance. External relationships… more
- Merck & Co. (Rahway, NJ)
- …cross-function teams to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable ... products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will… more
- Merck & Co. (Rahway, NJ)
- …and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (Rahway, NJ)
- …technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory , Quality , and Supply Chain from early development through to ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Merck & Co. (Rahway, NJ)
- …O3Job Family: Manuf/OperationsSenior Technician, OperationsPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development and … more
- Merck & Co. (Rahway, NJ)
- …oversee device risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires extensive ... implementation of risk control measures.Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management… more
- Merck & Co. (Rahway, NJ)
- …models in Enterprise Architecture repository. Implement governance standards for data quality , data lineage, security, and regulatory adherence. Conduct ... data integration, governance, and accessibility across the complex clinical development ecosystem. Reporting to the BIA team lead,... data and data standards across Clinical Development, Medical Affairs, and Regulatory Affairs… more
