- 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
- Abbott (Burlington, MA)
- …development and transfer to manufacture. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and ... will operate within a global quality system aligned to FDA 21 CFR Part 820 (transitioning to QMSR aligned...standard work across programs, helping the organization succeed through FDA 's QMSR transition while sustaining compliance to current QSR… 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
- 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...about. **Job Summary** We are seeking an experienced nonclinical drug development professional to serve as a Principal Scientific… more
- Amgen (Cambridge, MA)
- …Pharmacopeia (USP), International Conference on Harmonization (ICH), and Food & Drug Administration ( FDA ) guidance documents related to analytical method ... transfer and validation. + Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions. **What you can expect from us** As we work to develop treatments that take care of… 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...team that leverages cutting-edge science to support innovation in drug development and safety assessment. Your work will help… more
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