- HCA Healthcare (Las Vegas, NV)
- …utilization, financial reporting, performance improvement, use of technology, regulatory compliance, drug utilization, clinical education and staff development, ... management of appropriate drug utilization, drug spend analysis, and quality improvement activities. What you will do in this...+ Provide guidance to facilities regarding JCAHO, CMS, NQSF, FDA standards, and State Board of Pharmacy Requirements. +… more
- Element Materials Technology (Acton, MA)
- …Reporting to the Division Director, you will work closely with laboratory staff, quality teams, and support functions to ensure we deliver on customer commitments ... provides expert environmental monitoring and microbiology USP <797> and cGMP FDA compliance testing solutions to home infusion, pharmacies, hospital pharmacies, and… more
- WellSpan Health (York, PA)
- …based on research study requirements. + Assists investigators in evaluating the quality of care and compliance to protocol requirements. Follows by ensuring ... and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding… more
- Actalent (Eden Prairie, MN)
- …Instructions, and test procedures. + Train personnel to improve compliance with regulatory and quality requirements. + Provide technical, process direction, and ... Contribute to the success of our customers by ensuring quality through the auditing of the facility and production...data to focus improvement efforts so customer requirements and regulatory requirements are met. + Accurately record data (cGMP)… more
- Teleflex (Olive Branch, MS)
- …in Science, Medical Technology or related discipline 10+ years experience in Quality Assurance and/or Regulatory Affairs of medical products. Extensive knowledge ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...of FDA /ISO/CE QMS & Regulatory Requirements with proven audit experience. Broad… more
- Edwards Lifesciences (Jefferson City, MO)
- …+ Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work ... coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA , and international regulatory requirements + Ability to lead and mentor field monitors… more
- Taiho Oncology (Princeton, NJ)
- …for decisions resulting from the GSMT (eg update of RMPs, labeling, regulatory notifications). + Evaluates current processes and escalate as needed, to enhance ... around safety operations based on company conventions, aligned with ICH and regulatory guidance. Safety operations related questions include but not limited to: case… more
- University of Pennsylvania (Philadelphia, PA)
- …and data quality . * Adhere to all University of Pennsylvania, FDA and GCP guidelines. * Effectively and independently managing multiple trials while also ... requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing + Advance ... + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development… more
- J&J Family of Companies (Titusville, NJ)
- …their opportunities and limitations. + Knowledge of endpoint validation frameworks and regulatory requirements (eg, FDA /EMA) is highly desirable. + Proficiency ... with the Neuroscience Therapeutic Area, Clinical Development, Quantitative Sciences, Regulatory and Patient Reported Outcomes. **Key Responsibilities:** + Design,… more
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