- Merck & Co. (Rahway, NJ)
- …diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance , Safety, Process Development, Technical Services, Utilities and Validation. ... We are seeking a Growth and Improvement minded Senior Scientist, Engineering that can help drive our Strategic Operating Priorities.Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute - Prioritize… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Operations Organization. This person will be a key stakeholder in the maintenance of the multiproduct strategy and will have a leadership role in the ... introduction of new processes, materials, and technologies to the facility as well as transfer of processes out. The Assoc. Director of Support Operations (m/f/d) has a variety of key responsibilities. These responsibilities include: Leading a team engaged in… more
- Merck & Co. (Rahway, NJ)
- …scientific nomenclature to meet the diverse needs of the businessSupporting maintenance and testing for the reference data systems, including SDLCIdentifying ... opportunities to improve efficiency, effectiveness and quality and implement changesBuilding and maintaining excellent relationships with end users/stakeholders, including outreach and engagementIdentifying, evaluating, and/or developing new reference data… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Guidelines and Procedures.Support equipment and facility maintenance activities.Support equipment setup and cleaning and raw material ... inventory management activities.Support API release, and initiate, track and/or execute shipment of GMP materials.Foster a culture of collaboration, learning, and innovation.Serve as a technical mentor and process team member supporting the SSO Pilot Plant.-… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Guidelines and Procedures. Support equipment and facility maintenance activities. Support equipment setup and cleaning and raw material ... inventory management activities. Support API release, and initiate, track and/or execute shipment of GMP materials. Foster a culture of collaboration, learning, and innovation. Serve as a technical mentor and process team member supporting the SSO Pilot Plant.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Maintenance Specialist I (2nd or 3rd shift) as part of the Facilities & ... based in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell… more
- Aequor (Piscataway, NJ)
- …rollovers, QDROs, QMCSOs, distributions, loans, hardships and compliance testing.Oversee maintenance of employee benefits files, maintain group benefits database and ... update employee payroll records.Gather employee data and oversee the processing of monthly billings and the preparation of vouchers for payment of administrative fees for all group plans.Allocate group health and dental claims monthly and review… more
- Tris Pharma (Monmouth Junction, NJ)
- Facilities Maintenance Mechanic - 1st shift Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on ... headquarters has an immediate need for an experienced Facilities Maintenance Mechanic I for 1st shift.The Facilities Maintenance... Maintenance Mechanic I for 1st shift.The Facilities Maintenance Mechanic I is responsible for Maintenance … 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 ... 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the ... for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the… 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)
- …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
- 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)
- …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)
- …to conduct data analysis and generate reports.o Assist in the development and maintenance of data analysis tools.o Collaborate with the team to ensure the accuracy ... and reproducibility of analyses. Report Generation:o Prepare clear and concise reports, visualizations, and presentations summarizing analysis results.o Collaborate with team members to communicate findings and recommendations to stakeholders. Team… 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
