- Sanofi (Morristown, NJ)
- Job Title: Associate Director Quantitative Data Modeling Location: Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to ... to regulatory submissions and interactions from first-in-human studies through life-cycle management . This position, based in Morristown, NJ, requires the successful… more
- Sanofi (Morristown, NJ)
- …teams trainings Answer to medical questions raised by HA, EC/IRBs, sites Ensure quality of clinical data through continuous data validation, blinded ... and Clinical Case review for safety data and statistical surveillance for efficacy data ) Raise study or project-level issues to the project head and propose… more
- Sanofi (Morristown, NJ)
- …teams trainings Answer to medical questions raised by HA, EC/IRBs, sites Ensure quality of clinical data through continuous data validation, blinded ... capability to challenge decision and status quo with a risk- management approach Quality - focused, able to develop...focused, able to develop good practices, using a critical data -driven and risk management approach Multiple tasks… more
- Sanofi (Morristown, NJ)
- …Skills Desirable But Not Essential: Global trial experience Clinical operations, Statistical, data management Regulatory knowledge Why Choose Us? Bring the ... Briefing books etc.) Familiar with digital tools such as data analytics or agility to use them Quality...focused, able to develop good practices, using a critical data -driven and risk management approach Ability to… more
- Sanofi (Morristown, NJ)
- …assessments): Leadership skills: Advanced Risk Management skills: Advanced Project Management skills: Advanced Data Management skills: Basic Scientific ... the entire processes, including preparing protocols, recruiting subjects, collecting valuable data , managing budgets and timelines work with medical leads, data… more
- Sanofi (Morristown, NJ)
- …the key expert working with Contract Operations, Digital, and Legal to address data issues . Lead the proactive identification and implementation of strategic ... platform and general ledger. The Director will maintain essential data matrices including customer classifications, transaction type eligibilities, and product… more
- Wyndham Hotels & Resorts (Parsippany, NJ)
- …team results. + Business Analysis - A macro and micro perspective on property data with regards to PMS/CRS reporting, OTA management , opening forms, etc. and ... and accurate submission of property datapacks. + Maintaining high quality of property information by validating, market research and...identify opportunities and the root cause of issues to ensure process success. + Project … 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)
- …learned.clinicaltrialjobsEligibleforERPRequired Skills: Accountability, Accountability, Adaptability, Clinical Data Management , Clinical Development, Clinical ... quality activities within the assigned therapeutic area.- This includes operational quality management and inspection management activities.The CQOM will… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of ... maintaining compliance and quality .Must be able to discern the criticality of issues and communicate to management regarding complex issues .Ability to… more
- Merck & Co. (Rahway, NJ)
- …ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling and ... (3) years' experience in a functional area, such as Operations, Management , Quality , Technical Operations, Technology, Engineering Preferred Experience and… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Process Excellence Specialist III role ... is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …maintaining compliance and quality .Must be able to discern the criticality of issues and to communicate to management regarding complex issues .Ability to ... inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight… 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
- 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
- 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
