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PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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The Director, Regulatory Compliance is responsible for managing key regulatory and compliance functions for Market Regulation and Transparency Services (MRTS). Director, MRTS Regulatory Compliance page is loaded.
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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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Work within the student affairs and campus life response team protocols to provide crisis management support: assess severity of situation; consult with SSS staff and relevant offices (e.g., Health Services, Residential Life, Student Affairs, Counseling, Campus Police, etc.
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Performs testing as required for research, new product/process development projects, or process improvements in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards and organization procedures.
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Minimum of 8-10 years of relevant experience in government relations, legislative affairs, or related roles. Policy Advocacy: Monitor and analyze legislative and regulatory developments at the federal level.
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The Program Director reports to the Health Affairs Director of Program Development and Management and should be familiar with current/modern data-gathering techniques and technology, and have experience leading the work of large, federally sponsored program evaluation initiatives, such as those by the Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), or Centers for Medicare and Medicaid Services (CMS.
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Student data Management - Working closely with the Associate Dean of AA, works collaboratively with admissions, academic and student affairs and institutional effectiveness to manage student data for all CAHS academic programs.
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Support Hoxworth Blood Center’s safety, cGMP, and Quality Plan in coordination with the Division Director, Quality and Regulatory Affairs. It ensures effective qualification, use, maintenance, calibration, and repair of medical equipment used in the provision of blood, blood components, tissues, and derivatives in accordance with safety standards and regulatory requirements.
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Engage with Privacy Office, Legal, Government Affairs and Regulatory Affairs to evaluate business interpretation of market dynamics and ensure alignment with Interoperability strategy.
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OR BS degree in health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.
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Hiring Agency/Seniority Unit: Minnesota Department of Veterans Affairs/ Veterans Home-Minneapolis-MNA. To be considered, you must be included on a US armed forces permanent disability list with a disability rating of at least 30% or been rated by the US Department of Veterans Affairs as having a compensable service-connected disability of at least 30.
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ARM will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates.
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Dr. Thomas Frist, Sr. HCA Healthcare Co-Founder If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Radiology Regulatory Compliance Coordinator opening.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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regulatory affairs jobs Title: sr director Company: Amgen
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