- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the requirements of this role. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to ... for DS Therapeutic areas. This position provides expertise within Data Management by partnering with diverse cross functional...or changing existing standards.Serve as the subject matter expert from Data Standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the submission dossier, where applicable, and to ensure timelines and business objectives are met. Subject matter expert ( SME ) in 2 or more focus ... (DMCs) and due diligence activities for assigned product(s), as neededActs as audit/inspection Subject Matter Expert ( SME ) for safety surveillance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data cleaning needs for DS Programs / Studies.- Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and ... (JOCs). Develop Key Performance Indicators and ensure sufficient tracking.- Functional Expertise: Ensures all external data contains...diverse data sets and identifies any erroneous data . Lead Companion Diagnostics data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Accountability: Will serve to represent the Patient Safety department as subject matter expert in cross- functional teams or committees and external ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...PV operational activities for NAO; participate in audits/inspections as Subject Matter Expert ( SME… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …gather, document, implement and validate all system requirements for associated module(s).Serve as the Subject Matter Expert ( SME ) for respective modules ... of global HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to end. Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.Serves as Subject Matter Expert ( SME ) in preparation for and ... functionally to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end… more
- Merck & Co. (Rahway, NJ)
- … areas to lead the development of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug delivery and/or ... an enterprise levelStrong mentoring capabilities to build individuals and teamsRecognized as a subject matter expert in multiple drug delivery and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the Director, Content & Channel Strategy. Collaborates and serves as a subject matter expert with all areas within NNI and NNA/S ... management and related analytics. Collaborates with Headquarters Corporate Communications as a subject matter expert regarding social media and website.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert ( SME ) for internal audit ... demonstrated decision-making capabilities Provides medical and scientific expertise to cross- functional DSI colleagues.Responsibilities:Medical Monitoring:For studies in which Medical Monitoring… more
- Merck & Co. (Rahway, NJ)
- …assignment of resources, professional development, and performance management.May serve as a subject matter expert and/or participate on process improvement ... execution of Phase 1-4 clinical studies. Under the direction of the Program Lead , you will collaborate with global, cross- functional team members including… more
