- ThermoFisher Scientific (Wilmington, NC)
- …interest, serious adverse events and clinical outcomes events reported by study sites. + Performs data review as specified in the client contract and data ... studies, as requested. + Assists in writing (interpretation of safety and efficacy data ) and/or review of CSR, IND/NDA report, ICSR, signal detection reports,… more
- Sumitomo Pharma (Raleigh, NC)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... and mentoring. **Job Duties and Responsibilities** Advertising & Promotion Review Activities + Review and approve materials...+ 8 - 12 years experience in biotech or pharmaceutical industry with minimum of 8 years focused in… more
- Sumitomo Pharma (Raleigh, NC)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... on external engagement, MSL/cross functional input and impactful insights, supporting data generation, and data communication, education and awareness… more
- IQVIA (Durham, NC)
- …including sample size calculations, while consulting with internal and external experts. + Review eCRF and other data management documents. + Create or ... the same. + Use SAS and/or R to perform inferential analyses and validate key data derivations. + Interpret study results and review reports of study results for… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …+ Coordinates the reviews of relevant records, (eg batch records, quality control data , quality investigations, etc.) + Conducts root cause analysis in order to ... system metrics and creates detailed trend analysis reports. + Performs analysis of data , trending and provides metrics for Quality Systems, as required. + Ensure… more
- ThermoFisher Scientific (Greenville, NC)
- …investigations, and performance monitoring in a GMP-compliant environment + Contribute to data review and documentation for model-based and traditional process ... Us** At Thermo Fisher Scientific, you'll play a key role in advancing pharmaceutical manufacturing using innovative, data -driven approaches. Be part of a team… more
- Sumitomo Pharma (Raleigh, NC)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... + Coordinating and consulting with other departments on the content, review , and assembly of regulatory documentation. Ensure consistency, completeness, and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka ... develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Clinical Development, Value and Real-World Evidence, Regulatory, Medical Affairs, Data and Analytics, Digital Health and Commercial functions. Responsibilities ... on study concepts and study protocols in governance meeting and review processes + Prepare reports and presentations summarizing findings, recommendations and… more
- Actalent (Sanford, NC)
- …method validation and transfer processes. + Prepare technical reports, critically review data , and evaluate new instrumentation and analytical ... assays, and conducting data analysis and procedural updates. Additionally, the Scientist will review reports and data in accordance with cGMP and data … more
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