- Legend Biotech USA, Inc. (Raritan, NJ)
- …master batch records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, ... Legend Biotech is seeking Operations Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Operations Supervisor… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applicable Global QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and ... on applicable RD processes and quality standards for continuous improvement and operations excellence. Closely cooperate with the Global Audits and Compliance, PV/MA… more
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …which include API and drug product manufacturing, packaging and labelling operations , QC testing and release, and distribution for biologics and small-molecules ... Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position will assist in supporting several areas within Legal Operations , including but not limited to; Contract Management, Program and Grants ... company agreements. As necessary, negotiate with opposing party with support from manager or attorneys to resolve contract language disputes. Communicate daily with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... Data Management Data Operations team and serves both as a subject matter...This position reports to the Associate Director Data Management Operations . Business administration activities within the CDR system may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to avoid significant quality or patient. Execute all recall operations activities and process directed by management when necessary.Deviation Investigation ... or more years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities ... at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.Assists in the creation of SOP's and work instructions specific to CSO Supply Planning as requested.Responsible for updating relevant Trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , Cleaning ... SciencesMinimum 5 years of experience in Technical, Engineering, and/or Operations in a GMP production environmentExperience conducting, supporting, reviewing and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager ... resources and information from established internal contacts; consult with manager for decisions outside established processes.Routinely recognize and resolve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand attorney and the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products and to specific ... a brand attorney and lead legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology products.Acts as legal advisor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as IT Security Architect for assigned services. Relationships Reports to the Senior Manager - Global Security Operations - Americas. Will support the Advanced ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... Advises on issues related to financial transactions, procurement, financial operations , securities, tax, financial audits, real estate, and facility management.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and policy compliance regarding the Master Data Domain Works closely with Sr. Manager - Data Management Operations to support, communicate and build transition ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to resolve SAP S/4HANA-related issues efficiently and coordinate with the Service Manager for Priority 1 incidents to ensure timely resolution.The role also includes ... Contact (SPOC) during off-business hours to support critical business operations . This position requires strong problem-solving skills, excellent communication, and… more
- Genmab (Plainsboro, NJ)
- …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 ... influence over the refinement of Genmab's processes, both within the GCDS Operations team and cross-functionally to ensure scalability.It is expected that you will… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... to clinical supply planning and incorporate them into the team's operations . Focus on Customers and PatientsMake rapid, disciplined decisionsDemonstrates ethics and… more
