- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Director , Clinical Operations /CPM Sun Pharma Advanced Research Company, Limited Summary The Director , Clinical Operations /CPM is responsible for the ... development of a Clinical Operations Team in the United States. Work with Function...review. Act as primary point of contact from clinical operations for assigned trials. Oversee study start up activities… more
- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director , Clinical ... process, and contract review. Act as primary point of contact from clinical operations for assigned trials. Oversee study start up activities of CROs (eg Site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...and allow decision making.Responsibilities- Support Head, Global strategy and operations on projects needing to be coordinated with both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and ... Operations . In collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations , candidate is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Director , Diagnostic Sciences Global Companion Diagnostics Job Summary The Director ... members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations , Biostats and Data Management and Clinical Development. Responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Sr. Director Data Management contributes to the vision, direction and strategy for Data ... cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced… more
- Merck & Co. (Rahway, NJ)
- …understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director , MACS Operations and will be a member of the EF ... role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup...is expected to be a key part of an operations team and foster a culture of collaboration, learning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she will also serve as the Clinical Science… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations , Pharmaceutical Technology and others where applicable. Identifies areas… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and enhancing designated ... external vendors and resources to provide the necessary support for ongoing operations . Qualifications: Successful candidates will be able to meet the qualifications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always maintained and ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure successful implementation ... of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage programs, executes the Diagnostic development strategy for a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and provides written assessments of relevant medical topics, and supports PV Operations ' medical review function. This position supports a senior physician in ... evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event level AE causality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management.Develop a strong,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates will ... be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree an accredited institution in a science or in a technical field preferred- Master's… more
