- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance, industry competitiveness and operational excellence Oversight of performance management : Facilitates regularly scheduled call quality calibrations, ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- RMS Computer Corporation (New York, NY)
- … management * Resource management * Project communications * Risk & issue management * Procurement management * Data centre design * Vendor ... management * Cable infrastructure design and implementation * Data circuit management * Network design and...benchmarking process across the infrastructure domain * Reporting all quality assurance issues . The successful individual will… more
- Merck & Co. (Rahway, NJ)
- …Business Operations Technology product line (supporting applications related to Workflows, Planning, Quality , Compliance, Vendor Management ) you will spend a lot ... an experienced professional with a strong IT - Product Management background to help us shape the vision and...work and continuously assess priorities as new insights and data become availableDiscovery & User Research Lead continuous discovery… more
- Pfizer (New York, NY)
- … Data Management , Safety, Biostatistics, Regulatory, Study Management , Pre-Clinical, Pharmacology, Quality Assurance. Experience building consensus and ... all FIH programs through proof-of concept Set the clinical data review strategy, ensure quality data...change across all levels of the organization including senior management . Data listing review experience Critical thinker,… more
- Merck & Co. (Rahway, NJ)
- …acumen supporting pre- and post-implementation processes.Proficient in order processing, sales/customer data management , operational management and process ... and end customers.Develop strategic plans to develop or evolve processes/platforms ensuring data reliability/ quality , scalability and business rules to ensure a… more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... to ensure compliance with industry regulations.- Able to report any recurring issues or trends to management for further investigation.Cleanroom Environment:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high-risk supplier contracting. ... Provide Strategic Legal Counsel Interpret complex internal and external business issues related to contracting and recommend best practices and solutions Proactively… more
- Merck & Co. (Rahway, NJ)
- …guidelines, data integrity guidelines, engineering standards, and regulatory issues .- Provides technical, project management and system leadership.-Education ... Optimization, Product Formulation, Project Management , Quality Control Management , Regulatory Compliance, Regulatory Issues , Safety Compliance {+ 5… more
- Merck & Co. (Rahway, NJ)
- …Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware, ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… 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 ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... collaborate regularly with upstream operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operate PPM systems and processes.- Apply AI tools to automate and improve portfolio data quality .- Onboard new projects and teams to PPM systems.- Assist with ... training modules and support decision-making for global/regional projects Evolve Project Management (PM) Processes: - Contribute to improving project management … more
- ValSource, Inc. (Rahway, NJ)
- …Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… more
- Merck & Co. (Rahway, NJ)
- …Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, Deviation Management , Equipment ... and IT teams.Support establishment of GxP systems in the facility: Change Management , Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with CRO/ vendors/ ... the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead...with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical… more
- Merck & Co. (Rahway, NJ)
- …excellence in support of the portfolio of work, including interrogation of the data / science through technical reviews and exploring alternative ways to view and ... introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk… more
- The LiRo Group (New York, NY)
- …with backgrounds and focuses ranging from Architecture, Engineering, Construction Management and Operations. We implement BIM, Reality Capture, 3D coordination, ... Project Controls, Data Analytics, BIM Implementation Consulting, and much more. Come...top A/E firms by Engineering News-Record, LiRo-Hill provides construction management , engineering, environmental, architectural, and program management … more
