- Deloitte (Philadelphia, PA)
- …solutions + 4+ years of experience with Life Sciences Pharmaceutical R&D regulatory data lifecycle . Experience to include introducing new technologies like GenAI, ... immigration sponsorship may be available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating… more
- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... as needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical Logistics/Supply… more
- Kelly Services (Malvern, PA)
- …phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for ... departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead Process-Fit-to-Plant… more
- J&J Family of Companies (Spring House, PA)
- …discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development, and Clinical Supply Chain. This organization ensures ... delivery system is robustly developed, scaled, and supplied under rigorous quality and regulatory standards. We are seeking a Global Head of Data Science & Digital… more
- Organon & Co. (Plymouth Meeting, PA)
- …Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of strategy across the ... Additionally, cross-functional interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- Merck (West Point, PA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams. + **Reporting & ... on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory ... regulations.Quality systems, batch documentation, and inspection readinessTechnology transfer, including CMC documentation and scale-up proceduresSupply chain operations, vendor qualification,… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... as needed. + Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. + Participate in external… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... (L&A) opportunities. + Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. + Actively participate in… more