- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both clinical and ... in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are ... We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work...plan(s) including key milestones and timelines Ensure country and site selection meet study requirements Participate in the development… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of manufacturing build up ... capacity of person in plant representing QA. Provide QA support for GTx clinical and pre-commercial product disposition and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking a QA Batch Warehouse Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis ... exempt-level position is responsible for performing a wide range of activities to support the QA oversight of Warehouse activities. This position is responsible for… more
- Aequor (Devers, TX)
- …and approve all necessary UAT test scripts. DCT Verification and Validation: Approve Site Procurement Data Load Files in support of simulated to Production ... Cell Therapy SAP Sourcing Migration Lead Devens, MA site Work Schedule: Monday - Friday, Business hours...and acumen for successful ERP implementation. Consulting and Escalation Support : Act as the SAP Procurement and ASL Champion,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation ... and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... and partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with… more
- Marchionda & Associates, L..P. (Stoneham, MA)
- Experienced Civil Engineer Project Manager JOB DESCRIPTION: Marchionda & Associates, LP, is a highly regarded full services land surveying and civil engineering firm ... career opportunity with unlimited growth potential for a civil engineer/project manager experienced with grading, storm water and infrastructure design associated… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy and precision requirements primarily focused o pharmaceutical operations and support equipment Develop, test, and validate, automated and manual calibration ... proceduresDesign calibration schedules and intervals for site equipmentMaintain and troubleshoot calibration test systemsPerform calibrations to transfer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring...performance, ensuring delivery aligns with timelines and SOW.Provide direct support to team members in troubleshooting and problem resolution,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical ... on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: Consults with internal… more
- Insmed Incorporated (Phoenix, AZ)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Patient Support Specialist at Insmed plays a crucial role in the Patient ... Support Program, focusing on the intake of Program Enrollment...entry, triaging documentation, and supporting the Patient Services Case Manager team throughout the patient treatment journey. The role… more
- Merck & Co. (Durham, NC)
- …proactively providing developmental support , coaching and assistance to team members. Support compliance to Durham Site policies and procedures that promote ... we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our… more
- Merck & Co. (Durham, NC)
- …Description: The Sr. Maintenance Scheduler is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This ... Maintenance and Material Storage Facility (MMSF) and Teknika Facilities . This support position will focus on scheduling maintenance execution, SAP Data stewardship… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other...with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to… more
- Merck & Co. (Rahway, NJ)
- …and analyze data to support quality system metrics and planning. Support compliance activities such as site readiness, audits, inspections, and CAPAs. ... is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release,… more
- Merck & Co. (Durham, NC)
- …to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review ... we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our… more
