- Parexel (Tallahassee, FL)
- …with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support * Support RA representatives during audits/inspections, ... ensuring readiness and timely CAPA closure. * Provide local expertise and responses to inspection queries. Cross-Functional Collaboration * Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory… more
- University of Miami (Miami, FL)
- …from staff regarding regulatory compliance. + Assists in the implementation of audit processes and programs to ensure compliance. + Supports and coordinates the ... gathering of information and data for submissions to regulators as needed. + Works with department leadership in the implementation of corrective action plans in situations of non-compliance, monitors progress and ensures completion. + Monitors, tracks, and… more
- University of Miami (Miami, FL)
- …to, and maintain , department Knowledge Base. + Monitor application audit reports, and system monitoring software alerts (server, network, workstation, security, ... etc ); remediate issues. + Lead small projects; collaborate on large projects. Ensure adequate communication is maintained regarding project statuses, project and task priorities, timelines, etc. + Defines clinical system requirements jointly working with… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …internal quality standards. + Monitor training effectiveness and maintain audit -ready documentation for inspections. + **Stakeholder Engagement** + Collaborate with ... cross-functional teams, including Commercial, HR, Legal, and IT, to drive adoption and continuous improvement of learning initiatives. + Act as a trusted advisor to senior leadership on training trends, compliance risks, and capability-building strategies. +… more
- University of Miami (Miami, FL)
- …requirements. + Participate in internal audits and support external audit responses. + Maintain documentation of findings, recommendations, and resolutions. ... Reporting & Insights + Generate and analyze reports on revenue integrity KPIs. + Present findings to leadership and operational teams. + Support data-driven decision-making and performance improvement initiatives. This list of duties and responsibilities is… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …Establish governance frameworks for training compliance, including policies, procedures, and audit readiness. + **Program Development & Delivery** + Design and ... oversee GxP training programs for diverse functions (eg, R&D, Manufacturing, Quality, Clinical, and Commercial). + Develop innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + **Compliance &… more
- University of Miami (Miami, FL)
- …integrations, and reporting for financial operations. + Collaborate with Finance and audit teams to ensure compliance and data integrity. + Drive automation and ... process improvement across financial workflows. + Manage Workday Finance roadmap, release planning, and stakeholder engagement. + Provide leadership and mentorship to financial systems analysts and project managers. + Monitor regulatory changes and ensure… more
- University of Miami (Miami, FL)
- …part of the plan to resolve the deficiencies identified during the audit /monitoring visit. Provides updates to the study team and/or management regarding submission ... statutes and approvals (eg initial and amendments) during internal team meetings and upon request. Assists with various regulatory related projects under the direction of the Manager of Regulatory Department Specific Qualifications Education: Bachelor's degree… more
- University of Miami (Miami, FL)
- …inventory records and preparing dosage sheets. + Staff Pharmacists assist in periodic audit of controlled substances at nursing stations and in Pyxis units. + Staff ... Pharmacists participate in the drug use evaluation process and contribute to quality improvement activities. + Staff Pharmacists perform all other job-related duties as assigned by the Director of Pharmacy Services or her/his designee. This list of duties and… more
- Lockheed Martin (Orlando, FL)
- …risk and impact to overall system requirements \-Demonstrated understanding of audit techniques **Security Clearance Statement:** This position requires a government ... security clearance, you must be a US Citizen for consideration\. **Clearance Level:** Secret **Other Important Information You Should Know** **Expression of Interest:** By applying to this job, you are expressing interest in this position and could be… more