- Robert Half Accountemps (Wilkes Barre, PA)
- …and examining account information. * Manage fixed asset accounting and assist with regulatory filings, audits, and tax submissions . * Document and monitor ... and analyzing production data. * Familiarity with fixed asset accounting and regulatory filings. * Ability to reconcile accounts, including bank accounts and… more
- Sumitomo Pharma (Harrisburg, PA)
- …teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies (FDA, EMA) during IND submissions , clinical study reports, and ... programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- University of Pennsylvania (Philadelphia, PA)
- …and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions , amendments, continuing ... required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders) . Assist in the coordination of Phase I-IV… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …better understanding. + Processes reportability decisions and is able to complete MDR submissions . + Assist in the preparation of regulatory body additional ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820,… more
- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other ... that GRMW documentation developed by Medical Writers adheres to applicable regulatory guidelines and departmental standards. **How you'll spend your day** All… more
- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** The Senior Manager in Global Regulatory Medical Writing writes and edits clinical regulatory documents, including ... fundamental accountability, provides strategic supervision, and planning assistance for clinical regulatory documents. + Writes and edits clinical regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- …people to make a difference with. **The opportunity** The Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, ... and extensive accountability, strategic vision, and planning for clinical regulatory documents. **Travel Requirements** : International and domestic **Location** :… more
- University of Pennsylvania (Philadelphia, PA)
- …subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating ... to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and essential… more
- ARAMARK (Philadelphia, PA)
- …insurance programs. Individual will prepare timely and accurate underwriting submissions and support the administration and issuance of insurance documentation. ... for information, proposals, contracts, etc identifying potential liability exposures, regulatory compliance concerns, insurance program compliance and other enterprise… more
- University of Pennsylvania (Philadelphia, PA)
- …multiple locations across the health system, biospecimen processing, and regulatory management. This position involves working directly with several Investigators ... potential study participants. + Assist with IRB communications, including initial submissions , modifications. + Collect and report timely, valid, accurate data.… more
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