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Provide regulatory guidance, general issue management and strategic stakeholder engagement support to Corporate Affairs and business leaders. Humana Director Public Policy, State Affairs Madison , Wisconsin Apply Now Become a part of our caring community and help us put health first.
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The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
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The candidate will lead and manage FDA CBER IND & IDE application preparation and submission; IND & IDE maintenance including reports and amendments using Florence Healthcare eBinders; preparation for internal and external compliance reviews of FDA related regulatory documents; and assisting IND/IDE Study UW clinical Principal Investigators with protocol development for compliance with the Code of Federal Regulations.
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Experience working within regulatory standards and requirements such as SOX, HIPAA, GDPR, HITRUST is preferred. Minimum 5 years of experience in IAM with proven expertise in key IAM technologies like OKTA, Siteminder, Sailpoint IIQ, or CyberARK preferred.
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Designs and implements information assurance and security engineering systems with requirements of business continuity, operations security, cryptography, forensics, regulatory compliance, internal counter-espionage (insider threat detection and mitigation), physical security analysis (including facilities analysis, and security management.
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Strong understanding of overall drug development and production strategies, spanning across all critical product development disciplines (nonclinical, clinical, CMC, Regulatory Affairs, Quality, commercial strategy and development.
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Knowledge of regulatory requirements such as Health Insurance Portability and Accountability Act (HIPPA), HITECH, Payment Card Industry Data Security Standards (PCI DSS), and FIPS-140. Actively contributes to the ISRM strategic planning process by working with the Chief Information Security Officer (CISO) to develop and implement department strategic plans and action steps that support the corporate strategic objectives.
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Additionally, the role involves representing the organization in interactions with regulatory agencies, fostering a culture of excellence and continuous improvement within the Global Biometrics and Data Sciences, and serving as a thought leader in the field of real-world evidence.
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The UW-Madison Office of Legal Affairs (OLA) is comprised of 15 in-house attorneys who provide legal advice and representation on the wide range of complex and highly specialized legal issues affecting the research-intensive and flagship campus of the Universities of Wisconsin.
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Develop strong collaboration with internal and external stakeholders including Quality, Regulatory Affairs, Analytical Development, project teams, research organizations, regulatory authorities, and other key stakeholders.
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This leader conducts independent research to establish a basis for program changes, and stays current with regulatory developments and legislative agenda through association with Kohler Co.’s lobbying administrators in Washington, DC.The VP, Global EHS owns positions on the top corporate Sustainability core team, the top corporate stewardship committee, and the top corporate security and emergency event committee.
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Sitting within the Platforms, Technologies, & Software Solutions business unit of DVS, our ESG/EHS Technology group specializes in leading clients through solution planning, design, and implementation to digitize their business processes and reporting for regulatory compliance and environmental/social/governance needs.
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The Imaging Engineer ensures regulatory compliance, assists in inventory management, and may serve as an advisor to other TRIMEDX personnel on technical matters concerning specialty equipment. Work with Medical Physicist on accurate and aligned radiation outputs to ensure regulatory compliance and patient safety.
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Associate Dean, Academic Affairs assigned to the School of Science, Technology, Engineering and Mathematics. Nestled between two recreational lakes, Madisonians are offered year-round activities, including the Dane County Farmers’ Market located around the Capitol Square, more than 200 miles of scenic biking and hiking trails, world-class restaurants, and numerous festivals and community events.
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We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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regulatory affairs jobs Title: sr director Company: Abbott Laboratories in Madison, WI
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