- Dentsply Sirona (York, PA)
- …responsible for evaluating product complaints and post-market data to determine regulatory reporting requirements, ensuring timely and accurate submissions to global ... understanding, and the ability to synthesize complex information to support regulatory compliance and patient safety. Key Responsibilities: _Complaint and Adverse… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …design, and performance analytics. + Exposure to healthcare industry standards and regulatory environments (eg, MedTech, FDA , MDR). + Strong influencing and ... stakeholder engagement capabilities. + Excellent communication and data storytelling skills. + Project management and change leadership in cross-regional settings. + High proficiency in LMS systems, CRM integration, and BI tools. + Global scope: requires… more
- University of Pennsylvania (Philadelphia, PA)
- …and data entry + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the protocol and regulatory ... process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews,… more
- University of Pennsylvania (Philadelphia, PA)
- …contrast agents, including Hyperpolarized Xenon-129. These studies are conducted under FDA IND/IDE oversight in partnership with industry sponsors. The CRC-C will ... ideal candidate will bring prior experience supporting clinical trials under FDA IND or IDE oversight, particularly those involving investigational imaging agents… more
- University of Pennsylvania (Philadelphia, PA)
- …submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Job Description This position is ... processing of biological specimens and manage study data and regulatory files per GCP. + Work with Regulatory...QA activities, and handle monitor/audit visits with CROs, the FDA and other entities. + Correspond regularly with the… more
- CSL Behring (King Of Prussia, PA)
- …or reject promotional programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related SOPs and work ... reject material based on company practice, CSL policy, US law, and FDA regulations. + Collaborate with Commercial Operations Marketing, Legal, and Medical personnel… more
- West Pharmaceutical Services (Williamsport, PA)
- …processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the ... quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external… more
- University of Pennsylvania (Philadelphia, PA)
- …communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate ... protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Job Description Clinical Research Coordinator BWith minimal… more
- University of Pennsylvania (Philadelphia, PA)
- …and compliance activities, and is expected to follow all University of Pennsylvania, FDA , and GCP regulations. As coordinators advance in experience, they may assume ... obtaining informed consent under supervision, assisting with data entry, filing regulatory documents, and maintaining databases with oversight. With experience and… more