- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and ... with key high-level internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead. Responsible for safety … more
- Merck & Co. (North Wales, PA)
- …Development within pharmaceuticals life science industry as well as experience with Global Safety Case Intake, Processing, Management and Reporting. Preferred ... Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. ... for CSPV and develop strategies to maintain compliance with global PV regulations for individual case safety ...with global PV regulations for individual case safety reporting, periodic reporting and risk management. Develops and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on… more
- Genmab (Plainsboro, NJ)
- …the CSR Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data ... packages for Data Monitoring Committees Review and approve any amendments, corrections, and updates of data packagesExperience:Master's or PhD in a statistical discipline with 8+ of experience in relevant technical areaExperience in statistical analysis,… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU...labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This ... for study teams to ensure consistency and compliance across clinical study safety reporting and activities. Global Management Strategy and Goals and Procedure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy,… more
- Merck & Co. (North Wales, PA)
- …marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for late stage ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...us? The Position Security Developer II will support the Global Security Operations mission with Global Information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... with management from each US affiliate promote awareness and support the global Corporate Conduct Charter. Create and maintain a responsibility matrix for purposes… more
- Merck & Co. (North Wales, PA)
- …of medical drugs and vaccines for the benefit of patients and global human health.This position supports statistical programming activities for multiple and/or late ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas (eg, in new Therapeutic Areas). They are responsible to ensure alignment to global and HR training and onboarding plans. They will also be responsible for the ... trainers and knowledge management staff. Closely partners with line leaders, Global Development key stakeholders, HR organization in understanding, designing and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet aggressive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...management within Finance, Legal, IT, Quality, Compliance and Product Safety . Leads an Operations team comprising up to 4… more
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