- Prime Therapeutics (Boston, MA)
- …necessity criteria through evaluation of available clinical evidence (eg, FDA labeling, pivotal clinical trials, authoritative compendia, peer-reviewed literature). ... based upon business needs. + Collaborates with Clinical Operations IT, Quality, and Compliance as needed for program support. + Other duties as assigned **Education… more
- Charles River Laboratories (Wilmington, MA)
- …and enter accurate data entry into Internet Colony Management (ICM). + Ensure compliance with all local, state and federal laws governing the use of research ... 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
- Medtronic (Billerica, MA)
- …Conduct quality checks and inspections on soldered components to ensure compliance with regulatory and company guidelines. + Collaborate with cross-functional teams ... the medical device or electronics industry. + Knowledge of ISO and FDA regulations related to manufacturing. + Experience with lean manufacturing principles.… more
- Children's Hospital Boston (Boston, MA)
- …quality. + Implement protocol revisions consistently across sites. + Regulatory Compliance and Quality Assurance + Oversee submissions to regulators (eg, IRBs, ... FDA ) and ensure adherence to all applicable guidelines and safety standards. + Align regulatory strategies across sites and jurisdictions. + Monitor data quality and… more
- Charles River Laboratories (Shrewsbury, MA)
- …basic laboratory procedures and collect and record/document research data in compliance with Good Laboratory Practices (GLPs), Standard Operating Procedures (SOPs), ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Charles River Laboratories (Shrewsbury, MA)
- …and watering devices for proper function. * Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Charles River Laboratories (Wilmington, MA)
- …and enter accurate data entry into Internet Colony Management (ICM). + Ensure compliance with all local, state and federal laws governing the use of research ... 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
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Kelly Services (Boston, MA)
- …assurance protocols and procedures. + Collaborate with cross-functional teams to ensure compliance with regulatory standards. + Analyze quality data and trends to ... pharmaceutical industry. + Strong knowledge of regulatory requirements and industry standards (eg, FDA , GMP). As part of our promise to talent, Kelly supports those… more