- J&J Family of Companies (Irvine, CA)
- …and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. **You will be responsible for** ... : + Ensures compliance with global regulations and regulating agencies. Interpret the...on regulatory requirements and develop and maintain rapport with FDA reviewers, project team members. + Provides continuing regulatory… more
- J&J Family of Companies (Irvine, CA)
- …and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. **You will be responsible for** ... : + Ensures compliance with global regulations and regulating agencies. Interpret the...on regulatory requirements and develop and maintain rapport with FDA reviewers, project team members. + Provides continuing regulatory… more
- Mentor Technical Group (Monroe, NC)
- …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
- Trinity Health (Syracuse, NY)
- …participants. + Ensures that submitted research is reviewed efficiently and in compliance with state, federal and local regulations, and IRB policies and procedures ... by quality checking all submissions prior to IRB review. +...Institutional Official, IRB Chair, IRB Lead Staff, Integrity & Compliance leadership, Director Office of Clinical Research, and other… more
- Sumitomo Pharma (Santa Fe, NM)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- Endo International (Rochester, MI)
- …work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to ... May review and approve laboratory test data and documentation for completeness and compliance + Is alert to and detects abnormalities during performances of tests… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including ... of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors… more
- Endo International (Rochester, MI)
- …work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to ... + Reviews and approves laboratory test data and documentation for completeness and compliance + Is alert to and detects abnormalities during performances of tests… more
- Vantage Specialty Chemicals (Deerfield, IL)
- …** Compliance & Governance:** + Ensure ERP and related systems meet global compliance requirements (eg, FDA , GxP, REACH, ISO). + Lead master data governance, ... ability to work across time zones and functions. + Practical understanding of compliance ( FDA , GxP, ISO), MRP, batch processing, and manufacturing workflows.… more
- Stanford Health Care (Palo Alto, CA)
- …in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off- label… more