- Legend Biotech USA, Inc. (Raritan, NJ)
- …supervision. Comfortable with speaking and interacting with inspectors. Due to the nature of the Data Review process, this role is 100% onsite at the Raritan, NJ ... and commercial operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to eLIMS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data ... Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from sites/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Train Field Medical Affairs team on relevant disease state topics and clinical trial data . Review and approve resources for FMA Train Sales Teams on clinical ... data and Prescribing Information Train Market Access team on clinical trial data and Prescribing Information Review and approve Medical Information letters,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable ... Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and ... needs, FTE allocation, budget allocation, and assessment of needs including training, data review tools, etc. Standing PRG reviewer for mid-to-late-stage asset… more
- Insmed Incorporated (San Diego, CA)
- …of daily/weekly/monthly activities of staff and operational oversight of group, data review , schedule, and training.Potentially oversee QC technicians and ... interim reports, and reports for stability studies.Manage, report, and trend stability data in JMP software and/or Labware LIMS. Escalate out of trend observations… more
- Aequor (Seattle, WA)
- …for routine activities, such as experimental execution based on established protocols, data review and analysis. Organize findings for effective and timely ... communication of data , draw appropriate conclusions and design next steps. Maintain notebooks with detailed and timely documentation of protocols, study designs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …communicate key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory data including endotoxin, sterility, growth ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Information (PI)/ Informed Consent (ICs) Establish and ensure deliverables to/from Data Monitoring Committees (DMCs) Review and approve deliverables of ... stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …events and technical complaints including handling of refund of replacement requests Perform data entry and review of adverse events and associated technical ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and timely safety updates to management on matters concerning safety promotional review , safety labelling committee input, safety data analysis and contract ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Honda Development and Manufacturing of America (Raymond, OH)
- …to both function management side as well as team sideAuthorize: Lead regular test data review meetings and MaruQ preparation events to validate the hardware and ... regulatory targets. To actively manage test and development schedules and data input from multiple departments and divisions across HDMA. Key… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …grants, competitive contracts and/or solicitations, and the terms of commercial contracts. Will review and ensure accuracy of pricing data of budgets, review ... similar software products and have the ability to independently explain financial data to management and scientific personnel as needed.This position requires a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This role will also provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement ... activities. They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues.Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the establishment of benchmarks for system performance and use satisfaction. Regularly review performance data to identify areas of improvement and implement ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...costs, and outsourced FTE. Support budget coordination and tracking, review and audit all final bills, and assist in… more
- SPECTRUM (Ballwin, MO)
- …timeframe Ability to work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors Travel Ability: Office ... Identify fixes to defects raised. Identify system integration issues. Lead code review , debugging, and testing of software applications. Provide an LOE on a… more
- SPECTRUM (Glen Echo Park, MO)
- …English Ability to work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors Ability to apply company ... your career as a designer, architect, engineer, developer, operator, or data scientist. We are creative, disciplined, hard-working, complex-problem solvers that… more
- Aequor (Golden Valley, MN)
- …related to the analysis of samples for Medallion Labs Document results and review data Investigate any technical discrepancies on a timely basis Develop ... a strong knowledge of the analytical methods being used to analyze samples. Qualifications: 1-3 Years of Experience at a Microbiological lab. Bachelor's degree in Food Science, Microbiologic or related field - REQUIRED. Knowledge of microbiological plating… more
- APPLIED MATERIALS (Rowlett, TX)
- …engineers. Functional Knowledge Works on issues where analysis of situation or data requires review of relevant factors Business Expertise Receives assignments ... in the form of objectives with goals and the process by which to meet goals. Recommends changes to unit or sub-unit policies. Management reviews work to measure meeting of objectives Leadership Provides direction to employees according to established policies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data ... Ensure key messages are clear and consistent within and across documents.Critically review documents produced by other writers for scientific content and alignment… more
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