- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the company to quickly uncover new business opportunities through product data , input from external healthcare professionals, medical support to licensing, ... credibility.- Lead the US Medical Affairs organization and ensure medical and scientific input to the strategies for all brands at Daiichi Sankyo. Ensure alignment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure consistency in understanding and implementation across Programs. Participate in data standards team meetings and provide input for standards components ... centered around rare diseases and immune disorders. Summary The Manager, Clinical Data Standards is responsible for the development and sustainability of the Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to management on matters concerning safety promotional review, safety labelling committee input , safety data analysis and contract review and vendor management ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...to technical complaint handling at NNI and NNCI Risk-Based Data Insights: Responsible for the creation of KPIs for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of the ... files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation Provide input in internal/external study related ... study requirements Participate in the development and testing of clinical systems (eg, data capture, IxRS) Ensure internal and external systems are updated in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... as the subject matter expert for our products and related data within the Diabetes Therapeutic Area (Diabetes-GLP-1, Diabetes-Insulins, Digital Health,… more
- Genmab (Plainsboro, NJ)
- …discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information ... in developing an integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the CDT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in which Medical Monitoring activities are conducted in-house:- Provides medical input regarding country feasibility. Consulted on decisions related to clinical ... to the site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. Responsibilities Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning;… more
- Merck & Co. (Rahway, NJ)
- …regional execution, and the rollout to the countries, that guides TA scientific exchange ( input and output) and real-world data generation of all Research & ... a single global scientific communications platformDrives global, regional and key country expert input events (advisory boards and expert input forums) to answer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in which Medical Monitoring activities are conducted in-house:Provides medical input regarding country feasibility. Consulted on decisions related to clinical ... to the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design, participate in the UAT… more
- Merck & Co. (Rahway, NJ)
- … manager packages. Strong understanding of Enterprise Process Management to troubleshoot report/ input templates (in cases of master data or other validations) ... provide operations solutions reviewing and analyzing system and passive data governance reports to ensure high quality data... data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, ... by strategic and tactical priorities and require complex analysis of situations and data Establishes new or improved methods within field of expertise across EVP… more
- Merck & Co. (Rahway, NJ)
- …priorities and roadmap, translating business strategy into short- & long-term technology and data needs ensuring the business is fully enabled by IT capabilities and ... data .Enterprise IT is searching for an energetic and experienced...Prism solutionsProvides technical guidance to development and support resourcesProvides input on approach, design, and estimation of effortAdvises on… more
- Genmab (Plainsboro, NJ)
- …regarding Genmab's solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying ... & updates of areas of interest reflective of US needsProvides scientific input and strategic direction to the investigator-sponsored trial program for solid tumor… more
- Aequor (Bothell, WA)
- …perform lot file review including assessment of manufacturing records, test method data , deviations for GMP compliance to enable lot release, specifically: a. Review ... executed batch production records and test data to ensure compliance with approved procedures and GMP...with the reporting and presentation of department metrics includes input into reports to Management, annual product quality reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned ... guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for ... if applicableStudy planning and execution: As CSL for Phase 2 studies: Provides input on major milestones of trial, clinical trial plan and contingency planning,… more
- Novo Nordisk Inc. (WA)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... lead analyzes customer journeys to identify optimization opportunities, leverages data -driven insights for strategic decision-making, and collaborates with cross-functional… more
