- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study (-ies) utilizing Microsoft Project or equivalent.Lead the creation of the cross- functional Clinical Study Oversight Plan (CSOP) under the guidance of the ... Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction...The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- 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)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...support and may manage day to day functional excellence activities to include, but not limited to,… 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)
- …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)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a project manager this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations ... project or be partnered with a more senior project manager in support of a larger, more complex drug...complex or regional projects (within the scope of the Global Development Process and Functional Procedures) or… 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)
- …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)
- …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)
- …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
- 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)
- …join a global team of talented AI engineers collaborating with cross- functional teams to deliver innovative solutions. The ideal candidate will have a strong ... 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. (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
- 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
- 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
- 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 ... 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
