- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on interdepartmental study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports ... CAPA investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is part of our company's Research Laboratories and is accountable for managing the end-to-end integrated ... clinical supply chain across our company's portfolio to enable...resolution with system solutions across our company's GCS.Support business case development (Enhancement Prioritization Management Form) and maintain the… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance ... GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities...information. Requests for accommodation will be considered on a case -by- case basis. Please note that only inquiries… more
- Insmed Incorporated (St. Louis, MO)
- …a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Collect, synthesize and deliver HCP derived scientific ... to Insmed. Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational ... and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV service… more
- Merck & Co. (North Wales, PA)
- …the US Food and Drug Administration requirements for "Financial Disclosure by Clinical Investigators" for all marketing applications filed to the US FDA.- ... to the US Food and Drug Administration regulation for "Financial Disclosure by Clinical Investigators " for all marketing applications filed with the FDA as required… more
- Insmed Incorporated (San Diego, CA)
- …to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program ... prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study reports, statistical analysis plans,… more
- Merck & Co. (Rahway, NJ)
- …will be responsible for some or all of the following core activities: Case review/approval for assigned productsExpedited case submission according to timelines ... timelines outlined in applicable regulationsAnalysis of peer-reviewed literatureReview of clinical study dataParticipation in risk communication planningParticipation in the… more
- Merck & Co. (North Wales, PA)
- …access and identifies value evidence needs to provide strategic input into clinical and market development programs.- Brings strong payer and HTA/reimbursement focus ... and validate as required, study designs, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications.Works with… more
- Eisai, Inc (Nutley, NJ)
- …to understand best practices for establishing diagnostic and treatment algorithmsHelp develop case studies and share with health system C-suite to encourage adoption ... dynamics driving the US health care environmentSelf-starter with strong clinical acumen, solutions oriented and can function autonomously.Open, collaborative nature… more
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