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You will support data quality monitoring using official ICD-10 documentation guidelines and regulatory requirements in the Kaiser Permanente Health Connect electronic medical record system. Reporting to a Medical Coding Team Manager , the Medical Coding Reviewer I will conduct data quality monitoring of physician documentation to validate code assignment in compliance with the official coding guidelines as supported by clinical documentation in the health record.
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Collaborate with Manufacturing, Quality Control, and Quality Assurance in supporting internal and external cGMP compliant operations, regulatory audit preparedness. Experience with regulatory audits of cGMP manufacturing sites.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Experience and aptitude for development and implementation of translational or biomarker strategies, preparation of scientific publications, presentations, and regulatory documents is a plus.
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Prepare/review development reports, tech transfer and process validation documents, regulatory submissions. Familiarity with risk assessments and Regulatory submissions (especially BLA.
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Bachelor’s degree in environmental science, urban affairs/planning, sustainability studies, physical sciences, sociology, engineering, business administration, or other relevant disciplines. Our ongoing commitment is focused on creating business practices that advance racial and social equity, investments in community impact programs for the benefit of Black, Indigenous, and people of color (BIPOC), and expand upon project work related to racial equity and social justice.
$100,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Governance and Compliance – The CTE will lead all Microsoft Information Governance and Compliance capabilities to govern data for compliance and/or regulatory requirements, including the management of agency specific Microsoft 365 information governance, records management, and data conne tors (as applicable) to support data retention and deletion requirements.
$196,225 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience with Microsoft platforms, including M365 (Exchange Online, Endpoint Manager, Configuration Manager, Intune, Purview, Autopilot, Teams, SharePoint Online, Power Platform). Certifications such as ICAM/Okta, ServiceNow ITOM, ITIL, CISSP, or Knowledge-Centered Service (KCS.
$196,225 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Write, edit, and review analytical sections of CMC regulatory filings. Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
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Typically minimum of ten years relevant engineering, project management, and/or licensing/regulatory affairs experience. Experience leading licensing/regulatory affairs teams in achieving regulatory outcomes (i.e., safety evaluations, design approval/certification, license issuance) including experience managing interactions with expert advisory committees or equivalents.
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Frequent use of the telephone, PC, and other systems/ software applications (e.g., online research, LexisNexis and/or other FINRA regulatory systems, etc. Core functions in Regulatory Review and Disclosure (RR&D) include but not limited to disclosure review of Uniform Forms U4, U5, U6, BD, and BDW, Public Records Review, Criminal History Record Information (CHRI), Statutory Disqualification, Expungements, Formal Disciplinary Actions (FINRA, SEC, and other Self-Regulatory Organizations (SRO.
$126,600 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Interact with colleagues in other departments, R&D functions and Regulatory Affairs functions to deliver high quality dossiers and documents in accordance with business priorities. You will provide support across all of Regulatory including Operations, Strategy and CMC. This role will provide project management of multiple Regulatory workstreams.
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This position is responsible for collaborating with the commercial team to identify revenue producing opportunities within MSD's customer base.
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As a member of the Universities at Shady Grove (USG) leadership team, this position is responsible for providing leadership for facilities management and operations, master planning, facilities renewal, capital and campus projects, safety & security, space and scheduling, furniture, fixtures & equipment (FF&E), environment, health and safety (EHS), lab management, sustainability, and related regulatory compliance.
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The REDCap Clinical Data Administrator will play a key role in project planning, execution, and protocol close-out, ensure adherence to Good Clinical Practices (GCPs), regulatory guidelines, SOPs, and other customer directed guidelines.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Under the supervision of a senior staff from the Data Management group, the incumbent will work closely with colleagues from Biostatistics, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Germantown, MD
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