- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of...study activities with other relevant GOMA functions and the Global Medical Affairs Team. Regional and Functional … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross- functional team(s) in support of benefit risk ... with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross- functional team(s) in support of benefit risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is filed/archived according to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, ... 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. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... Global Team Leaders.Responsibilities- Creating and leading a high performing, cross- functional global project team composed of representative of asset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... teams and senior leaders from across Regulatory Affairs, as well as cross- functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resourcing and budget alignment in close collaboration with finance and functional team members.Maintains global integrated project plans, project timelines, ... role in a biotech or pharmaceutical companyDemonstrated success as a project manager /leader in planning and executing strategies for global drug development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical ... reviews and MSA discussions of External Vendors by engaging with key cross- functional stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations ... (GDO) ( Global Clinical Operations / Clinical Quality Management or other RD business process owners that applicable clinical development processes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, ... 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. (Basking Ridge, NJ)
- …a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development and management of other ad hoc special projects as ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with functional CMR stakeholders to develop, deploy, and archive functional … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reviews and MSA discussions of external vendors by engaging with key cross- functional stakeholders ( Clinical Operations, Clinical Biomarkers, Precision ... the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and… 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 ... Safety, NNI GXP Support, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP Auditor(s) as well as with counterparts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …America Ethics & Compliance. Frequently interacts with other E&C Leaders and functional areas (eg BPs, Education). Regularly interacts, and provides direction to, ... information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend 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)
- …a Senior Manager /Associate Director, External Manufacture as part of the Global Manufacturing Supply team based in Raritan, NJ. Role Overview This position will ... Person in Plant. Serve as the liaison between internal functional groups, such as global MS&T, Supply...of the projects, risk and mitigation strategy to the manager and cross functional stakeholders. Requirements BS… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial...a crucial role in supporting both the commercial and clinical supply chains at Insmed. The primary focus is… more
- Insmed Incorporated (Bridgewater, NJ)
- …Expert Engagement Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence ... - Create external MSL benchmarking and innovative external impact assessment capabilitiesCross- functional Alignment - Partner with Global Medical Directors,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend 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
