- 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
- Merck & Co. (Rahway, NJ)
- …challenges and issues to TA Head/CRD Clinical Research Director/CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team-(as appropriate).Identifies ... manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local study teams to high performance:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the ... decisions. Can apply financial analysis to build business cases that drive quality decision making and management processes.Travel is estimated at 30% of time,… more
- Eisai, Inc (Nutley, NJ)
- …Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information ... for adverse event reports for the assigned product area, codes and enters information into the global safety database as requiredCreates and reviews individual and summary reports for submission to the FDA and International Regulatory authorities.Interface… 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)
- …with strict adherence to local regulations, company SOPs and ICH GCP.As line manager the role is critical to continuously develop key talents by providing training, ... continuous development.Ensures CRA compliance to corporate policies, procedures and quality standardsExtent of Travel:up to 50%Qualifications, Skills & Experience:CORE… 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)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Aequor (New York, NY)
- …Minimum experience of 1-3 years in case management, utilization review and/or quality assurance Experience in episodic care, wellness care and counseling of adults ... Proficiency in use of electronic medical record keeping systems desirable BLS certification required Optional: Case Management and COHN-S certifications Major Responsibilities: Assist in coordination of clinical operations, including medical surveillance, OSHA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the Center for Data Governance ... outcomes.- Support the creation and us of policies, processes, data standards, data quality and enabling IT and digital technologies needed to establish and maintain… 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
- 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)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… 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)
- …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)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Ensures all systems and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment of system upgrades, ... including the scheduling of key activities and communicating of system downtime to appropriate parties. Identify opportunities for automation and reduction of manual processes across the team in conjunction with our Financial Disbursements roadmap.- Leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality , time, and cost and that Data Management documentation… more
