• Associate Medical Director/Medical Director…

    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
    ThermoFisher Scientific (07/15/25)
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  • Director, Regulatory Advertising & Promotion

    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 (07/08/25)
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  • Director, Medical Affairs Strategy (Prostate…

    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
    Sumitomo Pharma (07/30/25)
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  • FSP Principal Biostatistician- Early Phase…

    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
    IQVIA (07/15/25)
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  • Quality Systems Specialist

    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
    Glenmark Pharmaceuticals Inc., USA (07/16/25)
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  • PAT Scientist II

    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
    ThermoFisher Scientific (06/18/25)
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  • Senior Manager, Regulatory Operations

    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
    Sumitomo Pharma (07/18/25)
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  • Director, Quantitative Pharmacology, Clinical…

    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. (07/16/25)
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  • Director, Integrated Evidence and Digital Health

    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
    Otsuka America Pharmaceutical Inc. (07/01/25)
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  • Scientist - Analytical - Plate Based Assays

    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
    Actalent (07/22/25)
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