- Endo International (St. Louis, MO)
- …manufacturing processes. The overall objective of the position is to ensure product quality and site compliance to regulatory requirements. The Lead Validation ... best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team...+ Familiar with data integrity guidance from MHRA and FDA + Management of data integrity gap assessments and… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- Cardinal Health (Charlotte, NC)
- …both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training ... both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training… more
- Charles River Laboratories (Wilmington, MA)
- …an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of ... products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in… more
- Philips (Plymouth, MN)
- …the planning, execution, and resource allocation of clinical studies, ensuring data quality , adherence to budgets, timelines, and regulatory standards. + Acts ... as a subject matter expert on GCP, ISO, FDA , and global regulatory requirements, guiding best practices in clinical research, audits, and compliance. +… more
- Dialysis Clinic, Inc. (Albany, GA)
- …medical records and other sources; collect, submit and maintain study data and regulatory documents, and ensure compliance with study protocols in order to provide ... consistent and quality data. Provide superior healthcare utilizing medical knowledge and...Board (IRB) applications, CV's, medical licenses, case report form(s), regulatory documents binder, electronic data capture, etc.) as applicable.… more
- Pfizer (Cambridge, MA)
- …disciplines, eg, Clinical Operations, Data Management, Safety, Biostatistics, Regulatory , Study Management, Pre-Clinical, Pharmacology, Quality Assurance. ... of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results… more
- University of Utah (Salt Lake City, UT)
- …Solving Incumbent is responsible for assisting the University in preparation for regulatory audits by developing, monitoring and updating quality controls and ... submission, and experience in human subjects research. Must have a working knowledge of FDA , ICH , and other regulatory compliance; an understanding of medical… more
- Curia (Albuquerque, NM)
- …business objectives. + Lead complex projects with minimal oversight, balancing quality , validation, production, and regulatory considerations in all ... management systems and cleanroom aseptic facilities. + In-depth knowledge of applicable regulatory requirements and standards, including OSHA, EPA, FDA , JP, EU,… more
- Emerson (Austin, TX)
- …of CE Directives and Laws, FDA , OSHA NRTL, OSHA NFPA 70E, and other regulatory codes + Strong eye for business, risk vs. reward analysis. + Knowledge of the ... + Work with 3 rd party certification bodies and regulatory agencies to submit and deliver certifications of our...associations. * Perform preliminary design reviews (PDR) * Follow quality control procedures and follow Quality Management… more