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The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
$50 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Administrative Division Director oversees and manages financial and administrative affairs of the Division of Critical Care Medicine, Pulmonary Medicine, and Quality of Life and Pediatric Palliative Care consistent with standards of performance that ensure University, School, LPCH, and Department business standards and objectives are met.
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Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications. Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
$57 an hourExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Job Title: Senior Manager, CMC Regulatory Affairs, Biologics. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Bachelor’s degree in communications, human resources, psychology or another relevant field required; Master’s in Higher Education Administration / Student Affairs preferred. The Academic Affairs Coordinator works closely with the Academic Affairs Manager on the University Relations & Academic Affairs (UR&AA) team to create an exceptional experience for Arc’s growing community of faculty and students.
$44 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Work closely with the Academic Affairs Manager to design and implement infrastructure that makes Arc a great place to do science for faculty and students. Arc operates in partnership with Stanford University, UCSF, and UC Berkeley.
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Deep knowledge of ICH and regional CMC regulatory requirements, along with awareness of global and regional trends in CMC Regulatory Affairs. Experience representing CMC Regulatory Affairs on cross-functional and regulatory teams.
$100 an hourExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities. Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise.
$55 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
$100 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Applicants should have a law degree from an accredited law school and a minimum of eight years of relevant experience gained in private practice or as in-house counsel, ideally in the higher education space and with student affairs legal experience.
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10+ years of experience in Regulatory Affairs with a focus on CMC, ideally in oncology and/or immunology therapeutic areas. We are seeking a highly experienced Director of Regulatory Affairs for CMC to oversee and lead regulatory strategies in support of our oncology and immunology therapeutic programs.
$250,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience representing CMC regulatory affairs on regulatory and cross functional teams. Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Liaise with colleagues in Regulatory Affairs therapeutics teams, Client local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
$104.37 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience. Unique Selling Point of this role: This role is a great opportunity to get experience in a CMC RA team, develop knowledge of Regulatory Affairs, and while working in data entry, may support the Team in other regulatory-related activities, such as supporting preparation of straight-forward submissions.
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This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affairs organization and reports to the Executive Director of Global Medical Affairs, Hepatitis C. This is a global role that involves the development and execution of global strategies for products in the LIFE franchise.
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affairs job Company: Tjx Companies Inc in Foster City, CA
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