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O Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
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Work collaboratively with cross-functional members of the Firm’s global Finance & Accounting, Investment Operations, Legal, and Technology departments to ensure effective and efficient operations of the Regulatory Reporting program.
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Experience working with regulatory compliance requirements such as HIPAA, HITRUST, SOC2, PCI, etc. Sr. Director Information Security - Remote. Partner with the Chief Information Security Officer (CISO) to set department vision and direction aligned with security leadership and key business partners.
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Experience working within regulatory standards and requirements such as SOX, HIPAA, GDPR, HITRUST is preferred. Minimum 5 years of experience in IAM with proven expertise in key IAM technologies like OKTA, Siteminder, Sailpoint IIQ, or CyberARK preferred.
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Technical consulting for clients on regulatory compliance matters including permit management, routine regulatory reporting (i.e., air, hazardous waste [RCRA and non-RCRA], EPCRA, etc.) EHS regulatory compliance assessments and audits at industrial and manufacturing client facilities and where clients perform field activities.
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Considerable understanding of third-party risk management framework, regulatory expectations and leading industry practices. Interface with internal audit teams and regulatory representatives providing program adherence, emerging risks, roadmap and efficiency initiatives; key representative for third party program during exams and audits.
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Associate Degree or higher from a regionally accredited institution in Fire Science or related field and five (5) or more years of fire prevention and/or fire suppression and/or regulatory life safety code compliance.
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The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions.
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Comprehensive understanding of typical environmental impact reporting and statements (e.g., EIR, EIS) required by federal (e.g., USEPA, USACE) and state environmental regulatory agencies, and federal and state laws (e.g., NEPA, SEQR) for related projects.
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Familiarity with a broad suite of environmental regulatory compliance processes (Endangered Species Act, National Environmental Policy Act, Bald and Golden Eagle Protection Act, state routing and permitting processes for proposed wind and transmission line projects in the Upper Great Plains.
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Knowledge of regulatory requirements such as Health Insurance Portability and Accountability Act (HIPPA), HITECH, Payment Card Industry Data Security Standards (PCI DSS), and FIPS-140. Actively contributes to the ISRM strategic planning process by working with the Chief Information Security Officer (CISO) to develop and implement department strategic plans and action steps that support the corporate strategic objectives.
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Serve as corporate level data security and compliance subject-matter expert, advising on compliance with contractual data security obligations under applicable federal, state and foreign legislation, including technical compliance with FISMA, NIST and other regulatory/legal information security requirements (e.g., FERPA, HIPAA, Privacy Act.
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Is a global leader in professional information, software solutions, and services for the healthcare, tax and accounting, financial and corporate compliance, legal and regulatory, and corporate performance and ESG sectors.
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Familiarity with security frameworks and regulatory requirements CSA, NIST, PCI DSS, GDPR, CCPA, etc. Sr. Manager, Product Engineering - Data Loss Prevention. Develops and manages Cloud-specific security policies, standards and procedures e.g., CASB tenant management, proxy server management, firewall management, SSL/IPSec, security incident and event management (SIEM), data protection (DLP, encryption), user account management (SSO, SAML), password/key management.
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Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements.
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regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Cheyenne, WY
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