- 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)
- …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
- 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
- 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
- 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)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, ... management principles in design (and resolution) of key quality management system elements to ensure complianceTracks... quality systems by identifying and proactively resolving quality issues Develops, analyzes and compiles … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... across clinical, commercial, and enterprise domains. This role involves applying data interpretation and trend forecasting to identify market trends, leading a… 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)
- …validation, early and late-stage analytical transfers, analytical life cycle management , and release and stability testing. The successful candidate must ... closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to… 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)
- …Development, Engineering Standards, Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, ... sites. You'll build the foundation for long-term robust manufacturing, enhance data monitoring capabilities, and drive excellence in safety, compliance, supply, and… 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
