- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team ... based in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell… more
- Merck & Co. (Rahway, NJ)
- …(Piping and Instrumentation Diagrams), electrical drawings, and troubleshooting & maintenance techniques. In addition to technical expertise, this individual will ... computer skills including MS office, User Specifications for equipment. General maintenance of processing equipment.Oversee routine and preventive maintenance on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Supervisor, Maintenance (3rd shift) as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe CAR-T Supervisor, Maintenance is an exempt level position working within Technical Operations team. This individual will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review ... partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors).Lead respective ... and collaborate with respective regional leads to align and incorporate system maintenance controls.Collaborate across each functional area of HR working with COEs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position ... drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements across studies related to a similar compound. Develops and oversees the maintenance of the study specific SAE Flow Plan and collaborates with on behalf ... of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.Electronic Data Capture (EDC)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data quality and security, supported by regular audits, data maintenance and continuous improvement processes.Project Management: Effective management of timelines ... and deliverables, along with experience in Agile and Waterfall methodologies, is essential. Preferred SkillsPractical experience in SuccessFactors as a functional consultant or configurator or SuccessFactors Certification would be highly regarded… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meeting materials (PPT slides, meeting notes, training materials, etc.) Support maintenance and improvements to internal departmental website Develop reports to ... track key performance indicators (KPIs) and metrics Education/Experience: Proficient in ExcelStrong communication skillsExperience managing dataProject management and operational experience helpful Qualified candidates must currently be enrolled in an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical ... benefit-risk assessments for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes from a medical strategy standpoint to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with counterparts from (license) partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in ... cooperation with Legal Department and PV functions. Drive development of standards for information exchange with partners in cooperation with PV functions. Initiate the implementation of obligations deriving from these contracts. Organize and conduct periodic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Annual Reports: Responsible for the preparation, processing, filing and maintenance of all distribution and business license initial applications, and/or ... renewals. Responsible for tracking expiration dates and regulatory changes to ensure timely filing. Preparation of all applications and related documents and research for attorneys as to requirements, regulatory rules and state-specific changes so that final… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all current business requirements in the following areas: vendor master maintenance , invoice processing, cash forecasting, payment processing, monthly and quarterly ... accrual preparation, including:- The day-to-day Accounts Payable and TE processes- Month end and quarterly disbursement closing processes- Vendor software administration for various ancillary applications- Support of the current staff on issues resolution-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans, including training and support models, to ensure ongoing system maintenance and performance. 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 Bachelor's degree in computer science, information systems or related field required Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization to ensure smooth transition from system implementation to maintenance . Identify, assess, and mitigate technical, regulatory, and operational risks ... while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that are required to update both management and the business on the progress and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure accurate and high-quality deliverables. Ensure documentation and consistent maintenance of code, logs and output within a regulated computing ... environment.Create and maintain specifications as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. Develop, implement and maintain SAS programming standards and… more
- Merck & Co. (Rahway, NJ)
- …cross functional areas (eg DevSecOps, Cloud, etc) and responsible for the maintenance and operations of applications and products enabling sustainment of business ... platforms and applications. The role ensures the operational stability, maintenance , user configuration changes, performance, and compliance of an application… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Technology, our Research & Development Division Scientists, Maintenance , Automation, Plant Operations, and Safety), Engineering Firms, and ... Process-Equipment Engineering Design, Technical Operations,-Single Use Technology and Operation Maintenance . Required Experience and Skills: Minimum 7 years of… more
- Merck & Co. (Rahway, NJ)
- …Core and Local Labeling documents.You will be responsible for the development and maintenance of Core and US Labeling for assigned products, ensuring compliance with ... internal and regulatory standards.You will assist in the development and maintenance of Local Labeling for EU and other regions.You will serve as a subject matter… more
