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Establish relationships with peers in key functions including MAM, Asset Strategy Leads, Pipeline Commercial Strategy, HEOR, Market Analytics and Insights, US Pricing, International Market Access and US Government Affairs, US Public Affairs, and US Medical Affairs.
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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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Call on and secure relationships with senior leadership in Epidemiology, Primary and Secondary Research, Medical Affairs, Value and Evidence, HEOR, Marketing, Brand Management, Product Management, Managed Markets, Market Access, Data Analytics, and other areas within organizations.
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This position requires collaboration with the Center’s practicum coordinator, guidance and support to staff providing supervision to the doctoral interns and ensuring that the training program fits within the overall scope and mission of CAPS, Student Affairs and the University.
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Support data-informed management of graduate program economics and allocation of instructional resources in collaboration/concert with Academic Affairs Oversee all graduate programs, and collaborate with the Graduate Curriculum and Standards Committee on graduate curriculum, policies, and procedures.
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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 requirement.
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The Respiratory Sales Specialist implements all Respiratory/Ventilation sales activities and is responsible for achieving revenue objectives. The Respiratory Sales Specialist provides clinical and educational tools and programs to ensure successful understanding and application of the respiratory product line.
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Proficient in GMP manufacturing, quality assurance, regulatory affairs, and clinical operations. Deep comprehension of regulatory and technical aspects impacting business decisions.
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Applications will be accepted only from current permanent Farm Production and Conservation competitive status employees (Farm Production and Conservation; Farm Production and Conservation Business Center; Farm Service Agency; Farm Service Agency County; Natural Resources Conservation Service; and Risk Management Agency); and CTAP/RPL eligible candidates.
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Organize and assist with permit applications to the Environmental Protection Agency (EPA), Army Corps of Engineers (ACOE), NYS Department of Environmental Conservation (DEC), and other regulatory agencies.
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Act in compliance with Heritage Healthcare's regulatory and professional standards and guidelines. Hold a current Certificate of Clinical Competence in Speech- Language Pathology (CCC-SLP) credential offered by the American Speech-Language-Hearing Association.
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In-depth knowledge of USDA, FDA, and EU regulatory systems desired. Work within a cGMP environment and maintaining regulatory and quality compliance. 10+ years Downstream Process Development experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of Biopharmaceuticals (cGMP.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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Sitting within the Platforms, Technologies, & Software Solutions business unit of DVS, our Environmental, Health, and Safety Information Management (EHS IM) group specialize in leading clients through solution planning, design, and implementation to digitize their business processes and reporting for regulatory compliance and environmental/social/governance (ESG) needs.
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Perform FAI/CVI (Annual) inspections on all fleet vehicles including tractors, trailers, converter dollies, light-duty vehicles, and any other company-owned equipment in accordance with all federal, state and local legal and regulatory agencies.
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regulatory affairs jobs Title: regulatory specialist Company: Jobget in Lincoln, NE
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