- Merck & Co. (Rahway, NJ)
- … management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in empirical ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial...device systems.Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.Excellent communication,… more
- Genmab (Plainsboro, NJ)
- …and ongoing oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and protection policies.Works ... to fulfilling our purpose.The Role.The Director, Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data Privacy Program,… more
- Genmab (Plainsboro, NJ)
- …pharmacology and quantitative sciences operations including governance oversight, functional risk management , and resolution of critical systemic issuesDrive ... caring, candid, and impact-driven to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to be our best, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and… more
- Aequor (South San Francisco, CA)
- … science -related consultation to the study teams. We leverage cutting-edge data science and operation data management to facilitate the study start-up ... data -driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data...system as needed. Education & Experience Bachelor's degree in Data Science , Statistics, Computer Science ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a subject ... and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within the CDR system… more
- Merck & Co. (Rahway, NJ)
- …in HR processes to identify opportunities for automation and process improvement.Collaborate with data science teams to integrate AI models that can enhance ... payroll applications and collaborate with the Middleware team (Informatica, TIBCO) for data mapping.Manage and design IT risk assessments, including identifying,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non-compliance such as: different approaches to data review in conjunction with Data Management and Clinical Science , audit trail review for non-logical ... globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi… more
- Novo Nordisk Inc. (Los Angeles, CA)
- … identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us… more
- Genmab (Plainsboro, NJ)
- …approving the CV of PL/PMRisk ManagementIdentify study risks with the CTT and oversee risk management activitiesMaintain and oversee the CTT issue log and ensure ... caring, candid, and impact-driven to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to be our best, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include Medical & Science , Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Aequor (Framingham, MA)
- …and technical writing skills. Experience communicating with business partners and senior management . Experience with root cause analysis and/or risk assessment ... DEPARTMENT DESCRIPTIONS Manufacturing Science is a partner of biologics manufacturing operations...analysis. Lead the creation and use of digital process data analytic systems. Partner with internal and external functions… more
- Merck & Co. (Rahway, NJ)
- …and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include Medical & Science , Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include Medical & Science , Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams prepare for governance interactions. Independently manage interactions with clinical leads, data management , safety, regulatory, and QA team members, both ... implementation of study objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk ...or internally) to ensure robust oversight for study level data review, including trend evaluation and full risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data and communicate ... procedures (SOPs), validation/ qualification/ method transfer protocols, completed assay data and reports primarily for the quality control laboratories.Key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Strong understanding of the intelligence cycle, especially collection, assessment, and management of primary data Work independently with ability to guide ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
