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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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Bluebird bio is seeking an accomplished and adaptable Director Medical Affairs to join the medical affairs team, focused on our gene therapy programs for Sickle Cell, Beta Thalassemia, and CALD. You will be joining a passionate and committed flock, flying closely with medical birds as well as the cross functional teams.
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The Global Communications and Media Relations department is looking for an intern to work with promoting Foreign Affairs web content, issue launches, events, and more. The intern will support the rapidly- evolving media landscape and ensuring that Foreign Affairs materials reach their intended audiences.
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A degree(s) in business, communications, marketing, public relations, government affairs, political science, technical area of specialty or relevant field may be substituted per LCRA guidelines for certain years of experience.
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A master’s degree in either Higher Education Administration, Student Affairs, Business Administration, or a master’s degree in any field with significant experience. Robust experience (typically 8+ years) in increasingly responsible roles within enrollment management, academic affairs, student affairs, or associated professions within higher education.
$95,101 - $128,385 a year(student)ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
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Bachelor's Degree from an accredited college or university in a related field (e.g., social work, regulatory compliance, law, student affairs or related field) is ideal (An equivalent combination of relevant education and professional experience demonstrating the required knowledge, skill, and abilities to perform the functions of the position proficiently may be considered.
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In addition, the person in this role will have the opportunity to support other legal teams in USG Legal Affairs through drafting, reviewing, negotiating, and interpreting writer/producer agreements, nonwriting executive producer agreements, director agreements, and other entertainment-related agreements.
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Support other legal groups in the USG Legal Affairs team. Work with the Legal Affairs team and colleagues in the Law Department on major projects with long-term business implications. Must be authorized to practice law in the State of California (Must be either (1) a member in good standing of the State Bar of California; or (2) MIP registered in-house counsel in California.
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To enable continual development of your product safety capability, the job will require you to work effectively in a global context with your safety colleagues and across functions within R&D, Quality Assurance, Regulatory Affairs, Global Safety Surveillance, Process, Technology and Communications.
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Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs.
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Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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The Assistant Dean will serve as an advisor to the Dean and the Associate Dean for Academic Affairs in matters relating to student success in law school and on the bar exam. Work with the Dean, Associate Dean for Academic Affairs, the Curriculum Committee and faculty to evaluate curricular and academic programs and requirements to improve bar passage.
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regulatory affairs jobs Title: intern Company: Milliman
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