- Oracle (Trenton, NJ)
- …Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety. . Partner with engineering teams to ... **Job Description** Oracle Health is standing up a specialized clinical product management team focused on medical device-aligned products. This team bridges … more
- Oracle (Trenton, NJ)
- …-centered solutions for the client. Performs independently varied and complex analysis, clinical studies , innovate new product offerings on external customer ... Description** Responsible for driving the client through the design of clinical and business processes, solution and technology workflow, and successful adoption… more
- Sanofi Group (Morristown, NJ)
- … clinical decision-making using existing platforms and through novel studies + **Translate insights** into actionable medical strategies that differentiate ... Key responsibilities include: **Medical Strategy & Evidence Generation** + ** Lead ** the development and execution of comprehensive medical strategies for… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …analyses and reporting, etc. **Key Responsibilities:** + With guidance, acts as biostatistics lead on clinical studies or other non-molecule projects. + ... providing statistical consultation on clinical development plans, clinical trial design and clinical study... endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing… more
- Sanofi Group (Morristown, NJ)
- …contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data ... plans, study reports, integrated summary of safety, summary of clinical safety, and labeling + Review, preparation, and/or contribution to questions from… more
- Sanofi Group (Morristown, NJ)
- …contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data ... plans, study reports, integrated summary of safety, summary of clinical safety, and labeling + Review, preparation, and/or contribution to questions/requests… more
- Sanofi Group (Morristown, NJ)
- …of ISS, RWE, study data milestones, and budget specific to all studies defined in the Medical plan + Compliance reporting for CSS + Optimize communication ... 5+ years of project/program management or relevant experience in biotech/pharma or clinical /scientific environment + Ability to lead project and implement… more
- Sanofi Group (Morristown, NJ)
- … Lead and other evidence generation-related functions for the subcutaneous formulation: Clinical Study Unit (CSU), Real World Evidence (RWE), Health Economics ... and execute evidence dissemination and medical education plans. + Lead the Integrated Patient Journey (IPJ) strategy for subcut...support programs, CSRs, etc) + Oversee medical tactics and clinical study budgets planning and execution to… more
- Merck (Rahway, NJ)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... insight into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human… more
- Sanofi Group (Morristown, NJ)
- …and communication plans with Commercial and Investor Relations. + Direct management clinical lead . + Matrix leadership and dotted-line management toward all ... stages of drug development and helps assure that the group 's priorities are aligned with the strategic priorities of...R&D and CMC functions he/she ensures deliverables of preclinical, clinical and quality studies needed for development… more