• Associate Medical Director, Pharmacovigilance…

    Sumitomo Pharma (Trenton, NJ)
    …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
    Sumitomo Pharma (08/15/25)
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  • Equipment Engineer

    Bristol Myers Squibb (Summit, NJ)
    …+ Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + Advanced ... to effectively manage multiple tasks and activities simultaneously. + Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and… more
    Bristol Myers Squibb (10/02/25)
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  • Director Research and Development - Applegate…

    Hormel Foods (Bedminster, NJ)
    …abreast of regulatory changes and ensure R&D operations remain compliant (USDA/ FDA ). + Determine feasibility of project objectives, timelines, and deliverables, and ... set by the strategic business plans. + Ensure shelf-life testing and pathogen validation testing is completed prior to launch and is routinely verified and represent… more
    Hormel Foods (09/19/25)
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  • Automation Engineer

    Hovione (East Windsor, NJ)
    …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... health authorities, in the scope of the Qualification and Validation area - Lead functional teams or projects by...audits - Fluency in written and verbal English - Computer literate with good working knowledge of the MS… more
    Hovione (08/08/25)
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  • Manager, Biostatistics

    Sumitomo Pharma (Trenton, NJ)
    …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
    Sumitomo Pharma (08/02/25)
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  • Manager, PVRM

    Sumitomo Pharma (Trenton, NJ)
    …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
    Sumitomo Pharma (08/01/25)
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  • Specialist, Quality Compliance

    Integra LifeSciences (Plainsboro, NJ)
    …and approve quality documents requiring QA oversight (eg, IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier ... and standards, and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the CMC facility **DESIRED… more
    Integra LifeSciences (07/19/25)
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