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Regulatory Affairs Chemistry, Manufacturing, And Controls (CMC) Internship Overview. Regulatory Affairs (RA) CMC develops and executes regulatory strategies in Chemistry, Manufacturing, and Controls (CMC) which use science to tell the story of our products in a clear and compelling way that leads to those products reaching patients quickly.
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Interface and advise internal principal investigators, the IACUC, and animal care staff to ensure the program is within regulatory requirements for the use of animals in research. American College of Laboratory Animal Medicine (ACLAM) board certified.
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The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation.
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Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.- Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity.
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Preferred Qualifications Three (3) years of experience working with standards and compliance regulatory bodies such as Centers for Medicaid and Medicare (CMS), Illinois Department of Public Health (IDPH), Joint Commission and/or Occupational Safety and Health Administration (OSHA.
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The Interventional Radiologic Technologist reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
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Collaborate with internal and external stakeholders to achieve objectives, including but not limited to field sales force, legal, quality, compliance, market access, market insights, finance, regulatory, medical, clinical, scientific, operations, public affairs, executive management, health care professionals, etc.
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Possess CISSP certification (or similar) and knowledge of national and international regulatory compliances and frameworks such as ISO, SOX, BASEL II, EU DPD, HIPAA, and PCI DSS. Role, Responsibilities, and Deliverables:Develop a risk-based cyber security program which meets regulatory requirements and aligns with industry leading information security practices.
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Knowledge of and experience in working with regulatory agencies and funding sources, including DHS, DRS and CARF standards preferred. Ensures that policy, procedures and practices are in full compliance with all regulatory and accreditation agencies.
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This role collaborates with functions across the organization, including Commercial Leadership, Medical Affairs, Regulatory Affairs, Corporate Communications, Research and Development Communications, and International Public Affairs colleagues to identify and maximize opportunities.
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Medical Congress and Ad Board Innovation Lead is responsible for overseeing and executing key logistical deliverables for major medical congresses across various therapeutic areas as well as design and deploy an innovative Medical Affairs Ad Board Channel strategy across Pfizer Business Units.
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Programs include formulation development, capital expansions and upgrades, new packaging, and regional product launches across diverse set of regulatory requirements. Collaborate across global and regional Commercial, R&D, Regulatory, and Supply Chain leaders to ensure projects align to AN divisional strategies and project outcomes meet business goals while managing risk.
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The Cardiac Sonographer II reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
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Connection Services presents an exciting opportunity within our managed services division for a Senior IT Asset Management Analyst.
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Ensure disaster recovery program documentation and testing activities meet internal, customer, and industry framework or regulatory compliance requirements (e.g., PCI, HIPAA, HITRUST) Ensure disaster recovery program documentation and testing activities meet internal, customer, and industry framework or regulatory compliance requirements (e.g., PCI, HIPAA, HITRUST.
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regulatory affairs jobs Title: sr regulatory affairs associate in North Chicago, IL
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