- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high ... standards of data quality and compliance within Global R&D...to foster a culture of compliance and accountability in data management practices. The position also involves… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials ... to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations for ... oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...expertise in the resolution of lab related inquiries and issues such as conversion factors, translations, and textbook ranges.-… more
- Merck & Co. (Rahway, NJ)
- …Quantitative systems pharmacology, Model-Based Drug Development-, or scientific data management .Experience leading cross-functional teams, launching, and ... Research and Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data ,… more
- Merck & Co. (Rahway, NJ)
- …quality / productivity projectsManage product supply chain Integrated Risk Management (IRM) and Business Continuity Planning (BCP), including identification & ... in opportunities to improve business processesProficiency in project and portfolio management tools and techniquesStrong data analysis skills with competence… more
- Merck & Co. (Rahway, NJ)
- …and analyzing system and passive data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts to resolve ... all issues and discrepancies as data stewards responsible...Analytics technologies, including SACP, Datasphere, SAP BW, HANA, Master Data management and ECC. Strong understanding of… more
- Merck & Co. (Rahway, NJ)
- …Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... we serve. Problem Solving and Innovative Thinking :- Gathers and analyzes data and effectively responds to new or complex situations, developing creative and… more
- Merck & Co. (Rahway, NJ)
- …to work strategically and in a detail-oriented framework with all levels of management .Must have strong understanding of product management systems and tools, ... and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial… more
- Merck & Co. (Rahway, NJ)
- …Bioanalytical Assays, Biomarkers, Biopharmaceutics, Business, Cell-Based Assays, Change Management , Clinical Data , Clinical Development, Clinical Investigations, ... Asset Team is responsible and accountable for the end-to-end lifecycle management for our company's late-stage multi-tumor assets. This includes the breadth/depth… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... in compliance with CDISC and submission requirement, review submission data package and ensure its quality and...quality , proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues .External Engagement:Continuously review ... between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in...process improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality teams to support GRA meeting company policies for quality management (eg, completing requests/initiatives from the GSOP Committee)Proactively manage ... Engineering, Statistics, or related field required Experience:4 or More Years Experience in quality management in the pharmaceutical industry and quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the ... Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global efforts of teams in other regions. May directly manage complex safety issues related to individual case review, risk management , translational medical ... team in critical areas such as individual case medical review, risk management , aggregate safety reports, and translational medical safety. This role requires the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …automation and controls system software, hardware and associated interfaces inclusive of data management , issues , deviations, corrections, remediation and ... will be responsible in handling day-to-day activities inclusive of life cycle management , issues , deviations, corrections, remediation and improvement efforts of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support specific and real time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data entry, ... according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.Perform tasks on time in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues .Support Quality , Regulatory and Financial audits.Provide ... as supporting Procurement execution activities, cost analysis, inventory and vendor management - in accordance with company policies and site-specific procedures.The… more
- MUFG (New York, NY)
- …Sr Management communication and reporting + Build Management reports reflecting the quality of RWA data and disseminate to Liquidity / ALCO and senior ... provide more details. **Responsibilities:** + As part of the Data Management & RWA Capital team work...data governance including (and not limited to) identifying data elements, reporting data issues … more
