- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety ... Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of … more
- Merck & Co. (Rahway, NJ)
- … Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... in GRACS for business process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable… more
- Merck & Co. (Rahway, NJ)
- …Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... Division by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Data Platform Technical Lead is responsible for architecting, designing, implementing, and optimizing data pipelines, models, and consumption ... mechanisms for data across the clinical, regulatory, safety and quality domains. This role will work with...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … education and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... safety monitoring under direct guidance of a physician ( Global Clinical Leader or Physician Scientist). The clinical science...Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global… 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 ... well as other research areas centered around rare diseases and immune disorders.SummaryThe Global Head of Centre for RWD / RWE (CR2) Project Management and… 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. (Rahway, NJ)
- …will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure ... Required Experience and Skills :- Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.Familiarity with Capital Project systems… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in ... including SMT or other cross-functional teams. Oversees or tracks safety signals in the global electronic signal... surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s),… more
- The LiRo Group (Edison, NJ)
- …traffic and planning, ensuring their successful completion while adhering to quality standards, safety protocols, and project timelines. Ability to lead a wide ... Lead Civil Engineer US-NJ-Edison Job ID: 2024-2937 Type:...have delivered on that label time and again. Recently, Global Infrastructure Solutions Inc. (GISI), the parent company of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and macros and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Project lead on programming safety supports for safety signal detection, ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...is to provide statistical programming technical support to DS safety team on all statistical programming analysis 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
- 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
- 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)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and… more
