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Jobs in Virology by ASV - Clinical Regulatory and Operations Specialist. Clinical Regulatory and Operations Specialist. Act as a clinical research pharmacist consultant by collaborating with domestic and international clinical research networks to develop and implement clinical trials, direct start-up activities, coordinate clinical site preparation/renovation, assess factors that may significantly affect a site’s clinical research and pharmacy capacity/operations, and devise solutions and/or approaches to mitigate potential issues.
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Coordinates responses to and tracks requests from congressional committees, Members of Congress, and congressional staff regarding current law, legislative proposals, regulatory actions, and VVA member inquiries.
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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Strong understanding of regulatory requirements, standards, and frameworks such as SOX, NIST CFS, CIS Controls, etc. Find even more open roles in Ethical Hacking, Pen Testing, Security Engineering, Threat Research, Vulnerability Management, Cryptography, Digital Forensics and Cyber Security in general - ordered by popularity of job title or skills, toolset and products used - below.
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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Senior leader to advance BCBSA's legislative and regulatory policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program, impacting the tens of millions of Americans we cover, serve, and support in these programs.
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Ensure compliance with all regulatory requirements, including SEC filings, Sarbanes-Oxley (SOX) compliance, and tax obligations. You will work closely with executive leadership and key stakeholders to drive financial performance, optimize capital structure, and ensure compliance with regulatory requirements.
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Monitoring relevant legislative developments, regulatory guidance, and enforcement actions relating to privacy and data protection in the jurisdictions in which the company operates. Reporting to the Senior Vice President and Deputy General Counsel, Cyber & Privacy, the selected candidate will provide timely and practical advice on a range of privacy and data protection matters, effectively assess and communicate risk to the organization, and design and implement privacy-centric processes that address risk across the enterprise.
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Serve as liaison with regulatory representatives from other associations in the health sector. Advocacy - Leading voice with Administration officials to improve federal rules and regulations affecting Medicare, Medicaid, Duals, and CHIP. Work in close partnership with lobbying team to support congressional education and engagement, including federal lobbying activities on Capitol Hill, as well as with state officials focused on Medicaid solutions.
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Configure and customize ServiceNow GRC applications, including Policy and Compliance, Risk Management, Audit Management, and Vendor Risk Management, to align with industry best practices and regulatory standards.
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As a not-for-profit entity, FINRA (Financial Industry Regulatory Authority) operates under the oversight of the SEC and sits at the nexus of broker-dealers, policymakers and investors. FINRA is a registered trademark of the Financial Industry Regulatory Authority, Inc.
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Serves as a Special Agent trainee in the Office of the Inspector General (OIG) with the responsibility under the direction of the Special Agent in Charge (SAC), to assist with investigations and event inquiries as may be required to assure the integrity of operations of the U.S. Nuclear Regulatory Commission (NRC) and Defense Nuclear Facilities Safety Board (DNFSB.
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Explaining regulatory compliance and legislative guidelines including as related to COBRA, HIPAA, ERISA, Section 125, and Health Care Reform. Comprehensive knowledge of carrier products and services, industry trends, benefits administration, regulatory compliance and HealthCare Reform.
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You will facilitate collaboration with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
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Electrical System Design: Evaluate and design electrical, avionics and related systems for Hughes' broadband internet connectivity product, ensuring those designs meet performance, safety, and regulatory requirements.
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regulatory job Title: regulatory affairs manager Company: Johnson in Rockville, MD
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