- Parexel (Boston, MA)
- …**Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Monitoring ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- Parexel (Boston, MA)
- …preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content of Human ... in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff', Quality System Regulation (QSR), ISO 13485,… more
- Integra LifeSciences (Braintree, MA)
- …components, manufactured sub-assemblies and final product. Must have working knowledge of US Food and Drug Administration regulations, ISO 13485, and other ... (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties...regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …the American Association of Blood Banks (AABB) and the Food and Drug Administration ( FDA ). The Anatomic Pathology Division accessions approximately ... in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...to be based within the US Key Responsibilities System Administration & Configuration + Manage day-to-day administration … more
- Integra LifeSciences (Mansfield, MA)
- …+ Materials Requirement Planning (MRP) + Project management + Food and Drug Administration ( FDA ), International Standards Organization (ISO) **TOOLS AND ... compliance with local, state, and federal regulations and other agencies ie FDA , OSHA, ISO 13485. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Lead Mansfield, MA… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Event reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + ... event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA , IRB etc. + Establishing and maintaining regular communication with study… more
- Dana-Farber Cancer Institute (Boston, MA)
- …IND/IDE applications to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + ... studies to the IRB as well as assist with FDA submissions and IND management. Reporting to the CTIP...Ensure various regulatory reporting requirements are met, Study Sponsor, FDA , IRB, etc. + Serve as facilitator for study… more
- Bayer (Cambridge, MA)
- …the Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food & Drug Administration ( FDA ). The Phase 1 manuscript from this program was ... Disease and/or relevant neurologic diseases as well as thorough understanding of drug development process over different stages; + Adept strategic and global mindset… more
