• Associate Director, CAR-T Analytical Scientific…

    J&J Family of Companies (Malvern, PA)
    …for working with teams in the preparation of technical documents and regulatory submissions , participating in review, and contributing to development of ... for all analytical topics including method development, control strategy and regulatory filings supporting FIH through commercial licensure. + Leading the… more
    J&J Family of Companies (07/21/25)
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  • Associate Director, MSAT, Upstream

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream ... processing. + Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with… more
    Otsuka America Pharmaceutical Inc. (07/18/25)
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  • Biostatistics Research Scientist

    System One (Pittsburgh, PA)
    …of tables, figures, and listings (TFLs) for clinical trial publications and regulatory submissions . + Collaborate with cross-functional teams, including clinical ... accessible manner to stakeholders. + Ensure all statistical work complies with relevant regulatory guidelines (eg, FDA, EMA) and Good Clinical Practices (GCP). + Use… more
    System One (07/15/25)
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  • Clinical Research Nurse C/D

    University of Pennsylvania (Philadelphia, PA)
    …activities delegated to research coordinator who provides study related support (eg, regulatory submissions and data entry). Participate in core study team, ... will comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards. Job Description Clinical Research Nurse C Responsibilities + Work in… more
    University of Pennsylvania (07/30/25)
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  • Senior Statistical Programmer, Late Stage…

    Merck (North Wales, PA)
    …figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbant is ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
    Merck (08/16/25)
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  • Associate Principal Scientist, Statistical…

    Merck (North Wales, PA)
    …figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
    Merck (07/26/25)
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  • Lead Pharmacovigilance QC Specialist

    United Therapeutics (Harrisburg, PA)
    …Knowledge of data entry processing, from start to finish (QC, medical review, regulatory submissions ) + Prior clinical or post marketing experience **Job ... Location & Travel** United Therapeutics has the flexibility to hire this role remotely with a 20% travel expectation, OR based in our Durham, NC office with a hybrid schedule of three to four days onsite each week and with a 10% travel expectation. Travel may… more
    United Therapeutics (08/21/25)
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  • Scientist - Container Closure Integrity…

    Merck (West Point, PA)
    …and analytical platforms. + Support various biologics and vaccine post-marketed CMC regulatory submissions . + Lead strategic initiatives within departmental and ... cross-functional teams representing GQLMAS. **Minimum Education Requirement** + Bachelor of Science (BS) or Master of Science (MS) in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry,… more
    Merck (08/21/25)
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  • Senior Scientist

    ThermoFisher Scientific (King Of Prussia, PA)
    …high quality data and aid in drafting of sections for characterization reports and regulatory submissions . Keys to Success **Education and Experience** + A BS or ... MS degree in protein biochemistry, biophysics, pharmaceutical sciences or related fields + Scientist: 2+ years of experience of an MS degree **_In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related… more
    ThermoFisher Scientific (08/15/25)
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  • Sr Scientist

    Teva Pharmaceuticals (West Chester, PA)
    …ability to build cross-departmental relationships * Knowledge of CMC requirements for regulatory submissions (INDs, BLAs) and experience writing DP sections ... Preferred Qualifications: * Experience working with manufacturing sites, external service partners and CMOs * Familiar with single-use manufacturing technologies * Experience with application of Quality by Design (QbD) to drug product development * Strong… more
    Teva Pharmaceuticals (08/02/25)
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