- Fujifilm (Boston, MA)
- …when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- J&J Family of Companies (Danvers, MA)
- …and multi-functional team members. + Ensure compliance with all applicable ** FDA , ISO 13485, and GMP** requirements. **Required Qualifications:** + Bachelor's degree ... Working knowledge of **industry standards** such as IPC-A-610, J-STD-001, and FDA /ISO quality system regulations. + Excellent problem-solving, technical writing, and… more
- IQVIA (Boston, MA)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... be given to candidates with recent previous health authority experience (current or ex- FDA medical reviewers, etc.) and with strong a ba_** **_ckgroun_** **_d in_**… more
- Takeda Pharmaceuticals (Boston, MA)
- …proposed. + The Sr Director/Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... responsible. + Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. + Leads the GRT and… more
- Integra LifeSciences (Braintree, MA)
- …implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains ... preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred. + Capable… more
- Sanofi Group (Cambridge, MA)
- …the COA team in Sanofi asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead also takes direct accountability of ... strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local… more
- AbbVie (Worcester, MA)
- …and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and MHRA requirements. This role bridges the data stream from ... to data integrity. + Ensure adherence to regulatory standards (e, g FDA , GxP etc.) + Manage remediation efforts, utilizing risk management-based principles to… more
- Boston University (Boston, MA)
- …+ Expert understanding of policies and regulations guiding human research, including FDA , OHRP, ICH GCP, applicable NIH policies, etc. + Excellent writing skills ... + Expert understanding of policies and regulations guiding human research, including FDA , OHRP, ICH GCP, applicable NIH policies, etc. + Excellent writing skills… more
- Charles River Laboratories (Shrewsbury, MA)
- …use of laboratory animals. Knowledge of GLP regulations and other FDA regulations applicable to non-clinical testing programs. Excellent organizational skills and ... 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 elevate your… more
- Takeda Pharmaceuticals (Boston, MA)
- …SDTM and ADaM datasets as per CDISC IG (Implementation guide) and FDA TCG (Technical conformance Guide); contribute to process improvement initiatives for creating ... can be adapted to multiple studies; Prepare deliverables for regulatory submission to FDA /EMA/PMDA or other agencies (eg eCRTs, ISS, ISE, BIMO, P21 checks) and… more