- University of Pennsylvania (Kennett Square, PA)
- …high-energy environment. Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise in animal ... environment. Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise in animal experiments and… more
- Dentsply Sirona (York, PA)
- …(eg, PSURs, PMCF, trend reports). _Cross-Functional Collaboration_ + Works closely with Regulatory Affairs , Safety Officers, Medical Affairs , Quality, ... responsible for evaluating product complaints and post-market data to determine regulatory reporting requirements, ensuring timely and accurate submissions to global… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,...state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Penn Medicine (Philadelphia, PA)
- …Jersey, and Delaware. Reporting to the Senior Director of Government Relations and Regulatory Affairs , the Associate Director helps develop and implement Penn ... an advisor to the Senior Director of Government Relations and Regulatory Affairs on strategic initiatives and short- and mid-term planning activities, including… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs , medical writing, data management) to translate ... Management and Systems collaborating closely with MCA - Medical Affairs and Clinical Affairs - as well...completed on time, within budget, and in compliance with regulatory guidelines. + Design statistical analysis plans for clinical… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs more
- Wolters Kluwer (Philadelphia, PA)
- …The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic ... + **Cross-Functional Collaboration:** Act as a liaison between engineering, product, regulatory affairs , clinical, and QA teams to resolve… more
- Sanofi Group (Swiftwater, PA)
- …for health agencies in support of drug development, or equivalent experience in Regulatory Affairs or Medical Affairs . Knowledge of Vaccine Clinical ... the scope of the assigned franchise, prepared in accordance with regulatory specifications and strategic messaging to support the clinical development, marketing… more
- Edwards Lifesciences (Harrisburg, PA)
- …Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs , Biostatistics, R&D, QA and Marketing on clinical data ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
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