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The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Department of Health and Human Services (HHS) to further advance the mission and priorities of the Immune Deficiency Foundation (IDF.
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Reporting to the Sr. Manager of Digital Products, the Content Management System (CMS) Manager plays a dual role as an expert content manager and an exceptional people leader. Experience with popular CMS platforms like Drupal.
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Are in compliance with regulatory agencies, including but not limited to, Covered California, the Centers for Medicare and Medicaid Services (CMS), the California Department of Health Care Services (DHCS), and the California Department of Managed Health Care (DMHC), i.
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Experience with Fanuc, Haas, Zimmerman, CMS, Vertical Milling Machines- 3 axis & 5 axis machines. Experiencia con Fanuc, Haas, Zimmerman, CMS, fresadoras verticales: mquinas de 3 y 5 ejes.
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As the SAP Business Analyst, you will support and manage SAP Product Lifecycle Management (PLM) and SAP Master Data Governance (MDG) capability supporting the Research, Development and Engineering (RD&E) and Global Safety and Regulatory Affairs (GSARA) teams.
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Ensures compliance with current federal, state, and/or local laws and regulations including Centers for Medicaid and Medicare Services (CMS), and United Network for Organ Sharing (UNOS). Assists in the investigation of inquiries by regulatory agency (UNOS, AOPO, etc.
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The Director will ensure the proper preparation and coordination of resources needed to achieve regulatory compliance related to the CMS COP Quality Assessment and Performance Improvement (QAPI) Plan and QAPI Annual Evaluation, and The Joint Commission standards, Co-chaired Quality Committee related to performance improvement, to include the collection, analyses, reporting and on-going monitoring of quality and safety data needed to meet accreditation requirements.
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Categories: DAM Manager / User, Creative / Content Operations / CMS, Product Manager / PIM. Molson Coors is seeking a Content Manager for the newly created Enterprise Content Management team within the Molson Coors Digital Department.
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Ensuring all regulatory requirements are being met, such as NYS DOH, CMS, NCQA, and HEDIS, serving as internal auditor within the group. Maintains knowledge of current Case Management Society of America (CMSA) Standards, NCQA Standards, Case Management Program activities, and performs the activities as directed by departmental policy and leadership, current NYS DOH, CMS regulations and standards if managing members of Medicare programs, and other regulatory requirements as applicable.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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Significant track record in leading regulatory operations staff through major global submissions (NDA, MAA etc) Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Workflows for the Regulatory Operations function; ensure that Company's practices are in conformance with the latest health authority and industry submission standards.
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Adheres to all Corporate and Departmental policies and ensures all regulatory requirements such as DOH, CMS, Medicaid, and accreditation requirements such as NCQA , URAC and HEDIS functionalities are met or exceeded.
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Experience in Business or System Administrator is a plusExperience with managing vendors/consultants/partners (e.g. external publishing vendor)Strong understanding of Regulatory Operation comprehensive roleDesirablePrior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferredExperience with BLAs/NDAs/MAAs preferredExpertise in Veeva RIM, system implementation experience a plus.
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Familiarity of Product Lifecycle Management systems (PLM), Digital Asset Management systems (DAM), and Content Management Systems (CMS). Familiarity of Product Lifecycle Management systems (PLM), Digital Asset Management systems (DAM), and Content Management Systems (CMS.
$129,200 - $215,520 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory cms jobs Company: Metroplus Health Plan
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