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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management.
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Headquartered in Alphen aan den Rijn, the Netherlands, Wolters Kluwer is organized around four customer facing global divisions: Legal and Regulatory, Tax and Accounting, Financial and Compliance Services, and Health.
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Monitors regulatory compliance, company policies and procedures related to procurement management and ensure that all property employees are familiar with and understand the policies. Maintain vendor compliance for HMC to include: Notivus system, Contracts, and CR&R/PRA purchases.
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Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application. QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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Minimum of 1 year in roles focused on watchlist screening, customer due diligence, or KYC/AML compliance operation with complex compliance processes and systems. Ensures product features and processes align with applicable Discover compliance and risk management standards.
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Internal stakeholders include: VP Immunology, International Market Access and Pricing; Global Health Economics and Outcomes Research; Affiliates; Areas; R&D; Commercial; Medical and Regulatory; Governance bodies.
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The Regulatory Manager will be instrumental in helping to ensure the company successfully meets all compliance requirements while achieving critical deadlines for key regulatory demands.
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Define evidence generation strategies, including clinical development, HEOR and regulatory strategies for all Rx BA projects, across imaging agents, medical devices, digital therapeutics and software.
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Managing the IT portfolio within Abbott’s IT organization (BTS/Corporate Strategy & Solutions) with leaders from Abbott Quality and Regulatory, Corporate Engineering (including Corporate Environmental Health and Safety), and Global Security, developing and maintaining comprehensive Application Lifecycle roadmaps, expertise on the applications, and prioritization of projects and demand.
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Familiarity with Amazon Redshift, TrackWise, Maximo and other technology platforms supporting the quality and regulatory, engineering, and physical security business areas. We're looking for an experienced Business Relationship Manager to support our global Quality and Regulatory, Engineering, and Physical Security organizations.
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The Cyber Defense service will be developed with adherence to RCP policies, relevant industry frameworks, regulatory, compliance, and operational performance requirements. The Senior Cyber Defense Manager will report directly to the RCP Director of Information Security and provide the vision and strategic direction for building and running Reynolds Consumer Products' new stand-alone Continuous Monitoring, Vulnerability Management, Threat Intelligence, and Incident Response programs.
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4+ yrs with regulatory compliance and information security management frameworks. Strong knowledge of complex vendor risk-related issues through demonstrated experience managing vendor relationships, information security or regulatory compliance programs, and audits.
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Meet all radiation safety and licensing requirements in compliance with state and federal regulations and accrediting organization requirements for all facilities and operations in radiation oncology.
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Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE, Series 7 Top Off and Series 66 licenses, fully paid for and sponsored by Fidelity.
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regulatory compliance jobs Title: pharmacy technician Company: Cvs Health Retail in Lake Forest, IL
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