- Stanford Health Care (Palo Alto, CA)
- …Provides appropriate training as needed. Assists in preparing staff and areas for regulatory review and surveys TJC (The Joint Commission), DHS (Department of ... the manager/director at meetings, etc., in the manager's/director's absence. + Performs review of staff documentation to assure quality, regulatory , and fiscal… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …+ Ensure the **QMS** is compliant, effective, and aligned with corporate and regulatory standards. + Review **Device History Records (DHRs)** and ensure ... our **Quality Management System (QMS)** , ensuring compliance with global regulatory requirements, and preparing the site for inspections and audits. **Area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- BWX Technologies, Inc. (Erwin, TN)
- …interfaces. + Provide interface with NFS Management, customers, off-site customers, and regulatory agencies. + Review and recommend materials and equipment ... appropriate resources from functional groups such as Health and Safety, Regulatory Compliance, Laboratory, Environmental Services, and Engineering to ensure project… more
- Carnegie Mellon University (Pittsburgh, PA)
- …Animal Care (AAALAC), international accreditation site visits, and compliance visits by regulatory agencies. 11. Create/ review regulatory documents required ... compliance with regulatory agencies and facility standards. 4. Initiate and/or review requests for equipment used in the animal research facility and plans for… more
- Neuberger Berman (New York, NY)
- …applications, updating licenses, overseeing terminations, state registrations, and related regulatory reporting. **Key Responsibilities:** + Review and complete ... histories, terminations for cause, etc. + Coordinate study materials, and regulatory exam preparation for employeesMonitor and review email communications… more
- Merck & Co. (Rahway, NJ)
- …agencies, or investigators.-10. Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.11. Participates with ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- WCG Clinical (Cary, NC)
- …clinical software systems (eg for clinical site support, patient engagement, safety, regulatory review , etc,). + Commercial software delivery experience in a ... 21 CFR Part 11 validated environment is a plus + Proven track record of successfully launching products. + Demonstrated ability to make rapid and complex decisions that optimize across multiple, and at times, competing objectives. + Strong leadership and team… more
- Insmed Incorporated (NJ)
- …commitment to working closely with patient community preferredFamiliarity/experience with regulatory and pharmaceutical legal promotional review processesA track ... and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, and Commercial Operations… more
- Wipfli LLP (Milwaukee, WI)
- …monthly, quarterly and annual close processes and preparation of quarterly lender and regulatory reporting. + Review and approve complex journal entries and ... on the financial impact of accounting developments and complex transactions. + Review and approve technical memos, position papers, and accounting policies prepared… more
