- FirstEnergy (Reading, PA)
- …the FirstEnergy Pennsylvania Team reporting to the Vice President of Finance and Regulatory Affairs for Pennsylvania. The primary office location for this role ... will be in Reading, PA and the position will be onsite. **_Responsibilities Include:_** + Maintain a safe workplace for coworkers and the community based upon knowledge of potential hazards and industry regulations/requirements. + Provide sophisticated… 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Merck (Upper Gwynedd, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May Be… more
- PNC (Pittsburgh, PA)
- …be based in Pittsburgh , PA or Cleveland, OH. This role would support Regulatory Affairs with regulatory examinations and ongoing supervision activities, ... the coordination and implementation of the risk management program to meet regulatory expectations. + Under supervision, executes the risk management program within… more
- J&J Family of Companies (Spring House, PA)
- …Leadership, Performance Measurement, Process Hazard Analysis (PHA), Process Optimization, Regulatory Affairs Management, Risk Management, Safety Audits, Safety ... across portfolio and maintain adherence to standard operating procedures and regulatory requirements. + Collaborate with cross-functional partners across PSTS and… more
- Merck (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May Be… more
- J&J Family of Companies (Spring House, PA)
- …Leadership, Performance Measurement, Process Hazard Analysis (PHA), Process Optimization, Regulatory Affairs Management, Researching, Risk Management, Safety ... portfolio and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory… more
- J&J Family of Companies (Spring House, PA)
- …Measurement, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, ... tools and systems to guide decisions, improve efficiency, and ensure regulatory compliance throughout the drug discovery and development pipeline. Key… more
- Merck (North Wales, PA)
- …in global patient advocacy and engagement activities + US/global experience in regulatory affairs , medical and scientific affairs , and pharmaceutical ... Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. This position executes the patient… more