- Lilly (Indianapolis, IN)
- …the acceptability of real-world evidence (RWE) for informing patient safety and regulatory decision-making. In addition to work related to framework development, the ... evaluating potential safety signals and supporting communication with global regulatory authorities. + Collaborating with cross-functional teams (eg, regulatory… more
- J&J Family of Companies (Titusville, NJ)
- …and for final protocols, clinical study reports, and clinical components of regulatory packages/submissions. He or she may delegate some of these responsibilities, ... partners from global medical affairs, health care compliance, legal regulatory , and other relevant groups. + The VP NP...equivalent, MD/PhD a plus, Board Certification in Psychiatry or international equivalent is preferred + At least 15 years… more
- JPMorgan Chase (Plano, TX)
- Serve as a trusted advisor on a range of legal and regulatory issues and guide stakeholders on how those legal requirements are internally documented and maintained. ... JPMorgan Chase's material legal obligations and monitor for related legal and regulatory changes. The Office of Legal Obligations is a global firmwide program… more
- Lilly (Pleasant Prairie, WI)
- …that the products are fit for their intended use and comply with global regulatory requirements. The Site Quality Leader leads and responds to regulatory agency ... & inspection readiness. Host audits and inspections. Assure timely closure of all regulatory commitments. + Assure the adequacy & effectiveness of the site quality… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global ... the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures… more
- Lilly (Indianapolis, IN)
- …prediction, deviation analysis, complaint insights) aligned with corporate quality and regulatory goals. + **Define and Deliver High-Value Data Products:** You will ... lifecycle of data products supporting Quality Assurance, Control, and Regulatory Inspections-ensuring they are scalable, governed, and enable actionable insights.… more
- Abbott (Lake Forest, IL)
- …live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify ... software quality and cybersecurity for Informatics, ensuring compliance with regulatory standards and driving continuous improvement across software development,… more
- University of Rochester (Rochester, NY)
- …culture. + Monitor compliance with program guidelines, deadlines, and regulatory requirements, ensuring accountability across the Research Base. + Work ... Base faculty and staff across multiple NCI systems, including the NCI Regulatory Support System (RSS) and NCORP-SYS, ensuring accuracy and compliance. + Oversee… more
- Sumitomo Pharma (St. Paul, MN)
- …Team. + Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support ... company objectives. + Champion regulatory and technical documents for regulatory submissions...and external partners. + Available to travel domestically and international if/when needed. **Education and Experience** + PhD or… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global ... Coordinates with donor centers and shared services with external inspections (eg regulatory , customer, etc.). Aids with audit planning, audit responses, and Plasma… more