- Merck (Harrisburg, PA)
- …Experience and Skills** + Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the ... assigned programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific leadership to cross-functional study… more
- Humana (Harrisburg, PA)
- …operational efficiency. Ensure robust database security, backup, recovery, and regulatory compliance in alignment with Humana's standards. Monitor database ... within the enterprise architecture. Develop Python-based automation and data workflows. Document processes and solutions in accordance with established SDLC and… more
- CSL Behring (King Of Prussia, PA)
- …strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for ... limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent… more
- CSL Behring (King Of Prussia, PA)
- …to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). You are also accountable for ... limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent… more
- Fresenius Medical Center (Allentown, PA)
- …service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements. Functions as part of the hemodialysis ... all relevant functions necessary for the discontinuation of treatment - document . + Discontinue dialysis treatment according to established procedures, + Evaluate… more
- Fresenius Medical Center (Wyomissing, PA)
- …service philosophy. Adheres to the FMCNA Compliance Program including following all regulatory and FMS policy requirements. Functions as part of the hemodialysis ... all relevant functions necessary for the discontinuation of treatment - document . + Discontinue dialysis treatment according to established procedures + Evaluate… more
- Sanofi Group (Swiftwater, PA)
- …are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site ... in accordance with Regulatory requirements and Global Quality policies and standards. This includes providing Quality leadership across the site organization as well… more
- UPMC (Pittsburgh, PA)
- …of supplies; restocking exam/procedure rooms. + Comply with requirements of appropriate regulatory agencies (ie OSHA, CLIA, PA Department of Health). Maintain strict ... clinic procedures according to policy and procedure. Assist physicians with procedures. Document patient information into the medical record. + Answering calls and… more
- United States Steel (Pittsburgh, PA)
- …transaction processing, trade settlement, reconciliation, manager communication, document management, audit and compliance activities, investment reporting, ... documents for new private market investments. + Monitor and report on regulatory compliance specific to private market investments Ensure that investments align with… more