- Lilly (Philadelphia, PA)
- …Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority assets ... with senior management and across relevant functional areas. + Support regulatory strategy development and health authority interactions related to CMC; Drive… more
- Commonwealth of Pennsylvania (PA)
- …DESCRIPTION OF WORK In this position, you will serve as the District Regulatory Permits Coordinator, responsible for overseeing all efforts within the District to ... You will also independently evaluate and provide written feedback on E&S Plan submissions and permit applications prepared for PA DEP's Joint and Small Projects… more
- Guthrie (Sayre, PA)
- …coding and initiate corrected claims and appeals. Interprets payer guidelines, regulatory guidelines, contractual obligations and works with Department Management to ... processes and provides feedback to ensure accurate and timely clean claim submissions . Other Duties: 1. Utilizes Epic system functions accurately to perform assigned… more
- ICON Clinical Research (Blue Bell, PA)
- …will be doing:** + Serve as lead biostatistician for programs of studies, submissions , or on simple to complex individual studies + Oversee statistical activities ... that support ICON's interactions with clients and regulatory agencies + Review and approve statistical methods sections of study protocols, statistical analysis… more
- Commonwealth of Pennsylvania (PA)
- …summaries, and reports for completeness and accuracy of content related to regulatory requirements. Communicates findings in order to adjust or correct, and requests ... reviewing and analyzing documents for completeness and accuracy of content related to regulatory requirements AND I communicated my findings in order to adjust or… more
- J&J Family of Companies (Spring House, PA)
- …with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease area leader ... evaluation and develops the strategy and the content for regulatory documents. + Works with senior clinical staff, establishes...in drug development (including experience with IND and NDA submissions ). + Able to manage study start-up, and directs… more
- University of Pennsylvania (Philadelphia, PA)
- …of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators. ... of research protocols. Attention to patient safety, data integrity, and regulatory compliance is essential. This position requires adherence to University of… more
- Geisinger (Danville, PA)
- …support and educational programming to research faculty and staff. Identifies regulatory issues with human research protocols and provides procedural guidance for ... regulatory and compliance issues. Provides technical support for Institutional...an IRB Member and completes in-depth reviews of assigned submissions to assess IRB approval criteria and determine review… more
- Envista Holdings Corporation (Quakertown, PA)
- …growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced ... framework. + Assures that deliverables meet all relevant quality, safety, regulatory , serviceability, and reliability requirements. + Reviews code proposals and … more
- WellSpan Health (York, PA)
- …to various records. May prepare, analyze, and maintain cost data as required for regulatory and financial reporting, and new program submissions on an ongoing ... actual variance. + May assist in preparation of federal, state, and other regulatory reports. + Assists independent auditors with interim and year-end audit. Support… more