- 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 ... position offers a unique opportunity to shape the future of data -driven drug development, building foundational science that enables Formation Bio to identify… 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
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... projects as the leader of a cross-functional team.--Champion compliance and safety ; promote a culture of diversity, inclusion, and equity.Champion compliance and… more
- Genmab (NJ)
- …of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and ... authorities or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight… 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 ... team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including… more
- Genmab (NJ)
- …trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data packages for ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Merck & Co. (Rahway, NJ)
- …Adjuvants, Animal Vaccination, Chemical Biology, Chemical Engineering, Clinical Chemistry, Data Analysis, Development Projects, Drug Delivery, Executive ... developing, and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice… more
- Aequor (Pearl River, LA)
- …and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting ... with a passion for using high-dimensional single cell immune profiling data in conjunction with innovative computational approaches and systems immunology knowledge… more
- Insmed Incorporated (San Diego, CA)
- …Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to ... ensure accurate and reliable analytical data . Performs technology assessment to enable high throughput analyses, automation opportunities, and easy to operate… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to… more
- Merck & Co. (Rahway, NJ)
- …and 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
- Aequor (Pearl River, LA)
- …and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting ... programs. This individual will join as a member of Next-gen. Sequencing / Data Science to support scientific web application development projects. You will be… 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 ... of management experience in PV preferredMinimum of 5 years of Drug Safety /Pharmacovigilance experience, including both investigational and marketed products;… more
- Merck & Co. (North Wales, PA)
- …: This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow...preferredExtensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead ... R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (ie,… 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)
- …real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior for cleaning ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk factors with and for other technical departments (eg, Clinical, Medical, Safety , Data Management, Statistics). This position requires skills in working ... different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface… more
- Insmed Incorporated (San Diego, CA)
- …vector purification.Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.Author Standard Operating ... Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, NDA, or equivalent regulatory… more
