- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages with leadership across the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …high-level internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety ... around rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility ... DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of...field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the ... 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)
- … 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)
- …of medical drugs and vaccines for the benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting ... deliverables for global stakeholders. The Associate Principal Programmer will gather and...and colleagues in other related function areas. Primary Activities : Lead programming deliverables for multiple studiesProvide technical consultation and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... management, performance monitoring, continuous improvement activities that ensure the safety , effectiveness, and compliance of the company's products.- The… more
- Merck & Co. (Rahway, NJ)
- …compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area ... and stability testing for biologic therapies in clinical development, impacting global patient health and wellness.Responsibilities include, but are not limited to,… more
- Genmab (Plainsboro, NJ)
- …development programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development, approval and maintenance of ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for… 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 The Associate Director will be the lead who is responsible for ensuring that all aspects… 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 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)
- …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)
- …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 ...Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process ... 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)
- …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
- 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...on operational excellence in support of the patient journey Lead design, implementation and ongoing management of all programs… 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...with all levels of leadership within NNI. Essential Functions Lead the evolution of NNI's data & analytics governance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Hub (ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives Lead a team of Role-Specific Training Support ... 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… 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 ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding… more
