- Formation Bio (New York, NY)
- …of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to create a data -driven portfolio ... This position offers a unique opportunity to shape the future of data -driven drug development, building foundational science that enables Formation Bio… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Ingredients (API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety , Interpersonal ... enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact… more
- Genmab (NJ)
- …one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker ... authorities or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI ... management experience in PV preferredMinimum of 5 years of Drug Safety /Pharmacovigilance experience, including both investigational and marketed products;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of data entry convention documents, PVA reviews and SAE flow plan / data management plan reviews. Works with ICSR management and CRO/Vendor oversight ... experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products;… more
- Merck & Co. (Rahway, NJ)
- …concepts, tools, and requirements for all dosage forms (liquid, lyo, drug -device combinations)Review and approval of data and technical documentsAbility ... for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates...for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a… more
- Merck & Co. (Durham, NC)
- …Compliance, Communication, Computer Literacy, Data Analysis, Environmental Health and Safety (EHS) Management , Lean Manufacturing Tools, Management ... North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, warehouse, utilities,… more
- Merck & Co. (Rahway, NJ)
- …Clinical Research Management , Clinical Testing, Clinical Trial Development, Data Analysis, Decision Making, Drug Development, Intellectual Curiosity, ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Aequor (East Syracuse, NY)
- …used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and ... for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will execute… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated ... Clinical Research, Clinical Testing, Clinical Trial Designs, Clinical Trials, Cost Management , Creativity, Data Management , Geography, Initiative Activity,… more
- Merck & Co. (Rahway, NJ)
- …change management .Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Engineering, Applied Engineering, Chemical Engineering, Chemistry, Clinical Operations, Customer-Focused, Data -Driven Decision Making, Drug Product Development, Estimation… more
- Insmed Incorporated (San Diego, CA)
- …and as part of a team is crucial. Experience with laboratory data management systems (LIMS) and statistical software is preferred.Salary ... Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to… more
- Tris Pharma (Monmouth Junction, NJ)
- …apparatusWorking knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health ... MV lead for assigned projects regularly reporting status/issues to management , conducts laboratory investigations and recommends appropriate Corrective Action… more
- Merck & Co. (Rahway, NJ)
- …will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role ... facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices… more
- Tris Pharma (Monmouth Junction, NJ)
- …apparatusWorking knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health ... (OSHA) regulations and guidancesAbility to perform analytical testing, calculations and data analysis, as instructedAbility to perform wet chemistry and physical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …determine risk factors with and for other technical departments (eg, Clinical, Medical, Safety , Data Management , Statistics). This position requires skills ... trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of direct reports,… more
- Merck & Co. (North Wales, PA)
- …programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Business, Communication, Data Management , Data Modeling, Numerical… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab… 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 ... 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
- Aequor (Pearl River, LA)
- …in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the ... issues. Technician should have the ability to manage and analyze manufacturing data . Ability to take initiative to identify issues, troubleshoot, propose solutions,… more
