- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Operations Manager - Investigations and Compliance as part of the ... within Technical Operations . This individual will be responsible for overseeing Operations related Investigations and general Compliance , as it relates to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, ... for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to the development of local… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and quality tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to the Director, Case ... Review & Compliance Reporting within Patient Safety. This position works closely...appropriate Understands Patient Safety case processing and NNI contracting operations including tool and systems used, exceptions processes, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or ... and project management for assigned protocols in a country in compliance with-ICH/GCP and country regulations, Our Company policies and procedures, quality… more
- Merck & Co. (Rahway, NJ)
- …DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities ... and reconciliation, query management, and database lock preparation/execution, in compliance with our company's Standard Operating Procedures (SOPs) and ICH-GCP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and… more
- Merck & Co. (Rahway, NJ)
- …these capabilities and we minimize our risk of outages that can impact our operations .The engineer will also work with the Print Product Manager to adopt ... our IT and business goals. The engineer will also work with the product manager to establish our incident and support framework.The nature of the position requires… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provide input to process standards and tools to achieve excellence in trial operations and management.Monitor and ensure compliance and highest quality standards ... and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development, planning and implementation ... customer segments across the portfolio in partnership with brand teams. The Manager should assess external digital opportunities and threats, customer journeys, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations .The Senior Director, Clinical Operations provides expert strategic, scientific ... clinical development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop program strategy and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality departments… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the established RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... Technical Operations team based in Raritan, NJ. Role Overview This...problem solving and project management program to improve safety, compliance , cost, process stability building quality and efficiency into… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head of Legal Operations & Projects will drive the development, implementation, operation , and management of the company's legal operations function and will ... of the role is developing, implementing, and enhancing a Legal Operations Program and leading strategic legal projects. Relationships This position reports… more
- Tris Pharma (Monmouth Junction, NJ)
- …Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor (2nd shift) as part of the Technical Operations team… more
