- Lilly (Indianapolis, IN)
- …working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data + ... Responsible for the oversight and actions related to regulatory queries on safety-related topics + Acts as the GPS Medical lead at the time of acquisitions and… more
- AbbVie (North Chicago, IL)
- …and external venues including Senior Leadership at governance meetings, and authoring regulatory documents. This senior-level position is expected to have a high ... in safety pharmacology assessment, knowledge of industry best practices and pertinent regulatory guidelines, and a vision of future enhancements in the field. The… more
- Sysco (Pleasant Grove, CA)
- …policies and procedures in compliance with local, state, and federal regulatory healthcare requirements, Occupational Safety and Health Administration (OSHA) rules ... and regulations, Department of Transportation regulations and other regulatory agencies as applicable. + Ensure OSHA mandated programs...LTD, EPA, and HIPPA as required. + Supervise the Drug Testing Program (DOT and Non-DOT). + Collects … more
- J&J Family of Companies (Titusville, NJ)
- …of advanced analytics methodologies (eg statistical modeling, AI/Machine Learning) in the drug development process for areas such as immune cell profiling and ... novel applications for advanced analytics and high dimensional data in the drug development process, such as identifying, procuring and curating suitable data sets,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …impact on asset strategy. + Independently consolidate safety findings into regulatory documents, including briefing books, investigational new drug applications ... and execution of nonclinical safety programs to support the development of drug candidates from discovery to market authorization. The incumbent will be highly… more
- Sanofi Group (Cambridge, MA)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a… more
- Charles River Laboratories (Ashland, OH)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... management, interpretation, and reporting of study data, and assuring the regulatory compliance of these projects. ESSENTIAL DUTIES AND RESPONSIBILITIES: *… more
- Charles River Laboratories (Mattawan, MI)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... Associate Scientist in Discovery Bioanalytical is responsible for quantitative analysis of drug in body fluids and tissue from non-regulated and regulated safety… more
- Mount Sinai Health System (New York, NY)
- …and maintains overall responsibility for pharmacy operations in the Investigational Drug Service to enhance the reputation and service-orientation of the IDS ... Manager also collaborates and provides expertise in support of clinical investigational drug trials. The Clinical Pharmacy Manager will work collaboratively with the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight ... Biological Product Deviation and Complaints. + Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist...Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details.… more