- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing ... resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices. The position also involves risk-based validation of IT services and determining audit targets for GxP systems.ResponsibilitiesLeadership and Strategic ... Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data ... position requires demonstrated line management experience and the ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy and quality plan closely aligned with the Global ... QA and Development QA to provide QA advise wherever necessary for shared services between R&D and Medical affairs, particularly in case when issues impact Medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to implement new innovative manufacturing technologies.Key Responsibilities Individual will lead a team to support manufacturing investigations, capacity planning, ... with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as Subject… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …re-balance inventories supporting manufacturing activities to provide an optimal service level and performance.Key Responsibilities Interpret and analyze demand and ... coverage and supply readiness.Monitor supplier execution and deliverables of goods and services aligned with scope of work.Monitor product life cycles and alert… more
- Merck & Co. (Rahway, NJ)
- …evidence packages to be submitted to regulatory agenciesSupport the PaCES lead to coordinate the development, validation, implementation , and utilization of ... PaCES lead to collaborate with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint… more
- Merck & Co. (Rahway, NJ)
- …many diverse areas including Biological, Chemical, Automation, Safety, Technical Services , Process Development, Analytical, Regulatory , and Quality.As part ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …engineering, and data science expertise. We enable data, technology and services that accelerate our scientists' ability to discover and develop innovative ... team, the Product organization is responsible for implementing capabilities and associated services to advance the drug discovery and development pipeline. Our IT… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …risk areas ensuring comprehensive monitoring across all NNI departments, functions, services , and vendors. This position is accountable for delivering critical ... of compliance professionals to ensure robust monitoring of NNI departments, functions, services , and vendors in line with Ethics & Compliance program needs Provides… more
