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This position is part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and will be fully remote. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly managing a team of direct reports in the organization and will play a critical role in the timely, effective, and quality completion of a cardiac enrollment clinical study.
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The Corporate Audit Services (CAS) – Senior Audit Manager – Finance is a management position that supports the Corporate Functions, Regulatory Reporting, and SOX Administration Audit Director.
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UMN MS is led by Dean and Vice President for Clinical Affairs Jakub Tolar, MD, PhD. Dr. Tolar is an international expert in recessive dystrophic epidermolysis bullosa, and he maintains his research program on hematopoietic stem cell transplantation as a treatment for rare genetic diseases.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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This position reports to the Director, Global Partnerships and Government Affairs and will also work in collaboration with CMEO and CEO to define effective strategies for corporate and foundation partnership engagement.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
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POSITION SUMMARY:The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative CRA II will assist with the implementation and execution of study protocols and associated study documents for clinical trials, including clinical monitoring of AtriCure also includes the coordination of site activities from site start-up to site closure as needed.
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Experience in a pharmaceutical, Federal Drug Administration (FDA), other controlled regulatory agency or Current Good Manufacturing Practices (cGMP) packaging or manufacturing environment is preferred.
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Responsibilities Management of the Coordination with City, County, and Federal agencies to maintain regulatory compliance for entitlements and environmental issues. #CB #LI-DT1 Type Regular Full-TimeManagement of the Coordination with City, County, and Federal agencies to maintain regulatory compliance for entitlements and environmental issues.
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Tasks may include conducting and/or overseeing wetland delineations, inventories, and functional assessments; performing botanical and wildlife surveys; developing permit applications; planning wetland mitigation projects (including construction oversight); preparing environmental impact assessments; and negotiating with regulatory agencies.
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Demonstrates extensive knowledge of, and/or a proven record of success performing in a role that emphasizes analyzing client internal control practices and evaluating client compliance with import control regulatory requirements, and some knowledge of international trade and US Customs issues, such as:Associated documentary requirements;Knowledge of the analysis of client internal control practices; and,Knowledge of valuation of client compliance with import control regulatory requirements.
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Must have a strong understanding of a firm back-office and financial reporting functions such as reserve formula, FOCUS report, possession and control, stock record, general ledger, trade blotters, margin requirements, time critical regulatory functions (e.g., buy-ins, sell outs), record retention, access control procedures, and cybersecurity.
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Demonstrate a thorough understanding of outsourcing business models, regulatory drivers, data governance factors and risk management frameworks involved in third party risk management. - Advanced knowledge of applicable laws, regulations, financial services, and regulatory trends that impact their assigned line of business.
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What you will Bring: Juris Doctorate degree from an accredited Law SchoolActive license to practice law, with either admission to the bar of the State of Minnesota or a limited in-house counsel license to practice law in the State of Minnesota 4+ years of in-house, law firm and/or regulatory agency experience in the areas of ethics and compliance.
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regulatory affairs jobs Title: sr director Company: Planet Pharma in Crystal, MN
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