- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site… more
- J&J Family of Companies (Spring House, PA)
- …the coordination of consistent document uploads within the required regulatory document management system. Driving effective contributions to process ... Principal Scientist is responsible for writing documents, coordinating reviews, performing document quality control (QC) and managing (eg timelines, resources, and… more
- WSP USA (Pittsburgh, PA)
- …Federal Planning Team by providing technical input with site analyses, data collection, regulatory document review and will work independently to write project ... maps, site plans, master plans, development standards, stakeholder engagement, and regulatory compliance for a variety of client projects relating to site… more
- PNC (Pittsburgh, PA)
- …the models are conceptually sound and compliant with the pertinent internal and regulatory policies. Document and communicate results and findings in Audit ... that PNC Bank's high impact models comply will all applicable internal and regulatory rules and policies. You would additionally: * Serve as subject matter expert… more
- Sanofi Group (Swiftwater, PA)
- …requirements, quality standards and within the time allotted. + Author the CMC strategy document "Global Regulatory CMC Strategy Document " in connection with ... possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered… more
- WSP USA (Pittsburgh, PA)
- …Planner will provide technical leadership for site analyses, data collection, regulatory document review, technical writing, team coordination, and client ... international trips. + Experience applying principles of DoD planning and regulatory requirements to create innovative and tailored planning solutions. + Experience… more
- Sumitomo Pharma (Harrisburg, PA)
- …submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- St. Luke's University Health Network (Allentown, PA)
- …Workday operational and management reports as required by operations, management and regulatory agencies + Document , create, modify and test Workday operational ... system security and maintenance, system modifications, testing, report writing, document maintenance, system audits and recommendations for process changes. JOB… more
- Globus Medical, Inc. (Audubon, PA)
- …Clinical Affairs personnel, as needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions,… more
- Globus Medical, Inc. (Audubon, PA)
- …Clinical Affairs personnel, as needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for… more