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This new position will work closely with Global and Regional Market Access, HEOR, Marketing, Medical & Clinical Affairs, Research & Development, and Government Affairs colleagues to help ensure patients gain appropriate access to Abbott’s life changing point of care, rapid diagnostics.
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Advanced knowledge and understanding in the core areas of government affairs and policy (Stakeholder and Alliance Development, Government Relations, Political/Campaign experience, Access and Reimbursement Public Policy and Economic Analysis) to maximize colleague contributions.
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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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Leverage internal partners for successful development of case statements, proposals and event planning, such as Institutional Research, Grants, Student Success, and Educational Affairs/Academic Divisions, Communications and Engagement or President’s Office.
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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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6+ years of progressive medical/scientific affairs experience within the pharmaceutical, biotech industry or at a consulting firm that supports the pharmaceutical or biotech industry; at least 3 years driving medical strategy.
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Establish relationships with peers in key functions including MAM, Asset Strategy Leads, Pipeline Commercial Strategy, HEOR, Market Analytics and Insights, US Pricing, International Market Access and US Government Affairs, US Public Affairs, and US Medical Affairs.
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Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data; educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities.
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Is a market-leading, Global Information Services company focused on professionals in the legal, business, tax, accounting, finance, audit, risk, compliance, and healthcare markets. IT Security Associate Director - Compliance Lead will ensure an updated.
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The Director, US Regulatory Affairs Global Strategic Labelling, oversees the process and compliance of the global labelling, including critical implementation of label as driver process and efforts to harmonize US and global processes, to ensure the successful development and approval of product labelling, as well as compliant lifecycle management.
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The position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. 4+ years experience in Regulatory Affairs role. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
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This role also collaborates with functions across the organization, including Commercial leadership, Medical Affairs, Regulatory Affairs, Government Affairs, Patient Advocacy, Corporate Communications, Research and Development Communications and International Public Affairs colleagues to identify and maximize opportunities.
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Minimum of 10 years’ experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance. Directs and conducts periodic reviews and updates related to complex OEC policy and divisional/affiliate procedures ensuring clarity, applicability and compliance to OEC Global policy and external requirements with minimal supervision from ECO.
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Routinely collaborates with regulatory colleagues and management in other groups including Marketing, Marketing Operations, and other commercial groups, Medical Affairs, Legal, Corporate Compliance and global development and business functions.
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At least 9 years previous industry experience; 6 years in Regulatory Affairs or in a role closely associated with interpretation of medical and scientific data such as that associated with review of advertising and promotional material.
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affairs job Title: compliance Company: Circle in Mettawa, IL
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