- Eisai, Inc (Nutley, NJ)
- …without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran ... status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective operational functions to identify areas for… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the development and ... information to make sound business decisions to build business cases that drive quality decision making and management processes.Travel is estimated at 30% of time… more
- Daiichi Sankyo, Inc. (Hackensack, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager reports to the District Manager and is responsible for ... relationships with the customer and become a resource. Communicate with the District Manager on a regular basis and discuss issues and opportunities. Represent the… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... least 5 years of enterprise-level governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC),… more
- Aequor (New York, NY)
- …recommend business operations improvements for GCS. Partner across GCS and quality to measure, and monitor supplier operational performance, establish action plans, ... track progress, report and communicate to ensure GCS relationship, financial, quality , and operational objectives are achieved. Act as a GCS point of contact for STP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product… more
- Merck & Co. (Rahway, NJ)
- …Safety, Process Development, Technical Services, Utilities and Validation.-The Project Design Manager (PDM) Associate Director will lead project teams thru the ... be to fulfill the role as a Project Design Manager (PDM) on capital projects; responsible to manage, lead...externally with Site Operations, Global Safety and Environment and Quality partners.During early phases of Front-End Loading the Project… more
- Merck & Co. (Rahway, NJ)
- …and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical to continuously develop key talents by providing ... of the country capabilities. The role will collaborate with country Partner Line Manager 's ( PLMs) to ensure alignment across all monitoring functions. The person… more
- Merck & Co. (Rahway, NJ)
- …highly motivated candidate to join our team as a Pilot-Scale Operations Lab Manager . This role involves managing, organizing, and providing support to the laboratory ... ensuring compliance with all relevant regulations and guidelines.Calibrate, conduct quality control, and maintain lab equipment, including cell culture analytical… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Study Associates, under the guidance of the Associate Director, will ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process and procedures. ... (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development and management of other ad hoc special projects as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the process ... redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews and provides input to SOPs, SOIs, and process guides.Qualifications: Successful candidates will be able to meet the qualifications below with or without… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and ... within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the...to plan within contracted time frame and budget, meeting quality standards. Determine the critical success factors for the… 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 ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... service disruption is required.- Strategic Planning- Under the guidance of the Manager develop and implement business operational strategies that align with the… more
