- University of Pennsylvania (Philadelphia, PA)
- … regulatory staff meetings, research team meetings, and ongoing protocol training/ compliance meetings. The Regulatory Affairs Start-Up Specialist- is expected ... and source document tools, as well as, to provide direct regulatory / compliance guidance and oversight of investigator-initiated trials and investigator-initiated… more
- Merck (North Wales, PA)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck (West Point, PA)
- …Analytical Technology (PAT), Professional Networking, Project Portfolio Management (PPM), Regulatory Compliance , Regulatory Submissions, Results-Oriented {+ ... developing analytical methods, assay transfer to GxP laboratories, and supporting regulatory filings including INDs/IMPDs and BLAs.- The successful candidate will be… more
- Merck (West Point, PA)
- …GLP and clinical sample analysis with a commitment to scientific excellence and regulatory compliance . Position Summary We are seeking a highly talented and ... data management systems that enhance sample tracking, bioanalytical data analysis, and regulatory compliance . The ideal candidate will have a strong background… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** ... trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible… more
- Wells Fargo (Philadelphia, PA)
- …of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance ), which includes effectively following and adhering to ... execution of credit related functions and portfolio support for insurance and insurance services clients. **In this...compliance , as well as adherence to policy and regulatory requirements to include those connected with leveraged credit… more
- Humana (Harrisburg, PA)
- …and assess the impact of changes in tax laws, accounting standards, and regulatory guidance, particularly those affecting health insurance and health care ... 740 and SSAP 101, supporting our financial integrity and regulatory obligations. The ideal candidate will bring deep technical...under ASC 740 and SSAP 101, ensuring accuracy and compliance with US GAAP and statutory accounting principles. +… more
- University of Pennsylvania (Philadelphia, PA)
- …physicians and coordinators' CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with IRB, study sponsors ... subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating… 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
- Highmark Health (Pittsburgh, PA)
- …development including gathering appropriate documents; monitoring particular legal or regulatory developments; engaging in research, cite check and retrieval of ... regulations; and developing information for reviews, reports, accreditation submissions, regulatory filings and court documents. Responsibilities include performing a… more