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Through a comprehensive understanding of the diagnostic and care landscape, the candidate will closely collaborate with the International Business Unit (IBU) marketing and medical teams, Government Affairs, and International Communication teams to execute, in partnership with the local affiliate teams, integrated solutions designed to remove obstacles to optimal patient pathways.
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The ideal candidate will be instrumental in developing a new major in international business and contribute to existing majors in international affairs and public policy. The ideal candidate will be instrumental in developing a new major in international business and contribute to existing majors in international affairs and public policy.
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This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
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This role will report to the Senior Vice President, Global Value, Access, Public Policy and Government Affairs. This role is responsible for leading the HEOR development and execution of the global evidence teams, engaging closely with and guiding the product development teams across our pipeline, supporting our regions and affiliates, as well as leading our V&A engagement with external stakeholders on evidence and access.
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This role will be responsible for delivering quality and timely medical input and interpretation on specific program data in fulfilment of the program objectives, working in partnership with regulatory affairs and pharmacovigilance in providing medical support for pharmacovigilance activities, responses to regulatory agency queries, and development.
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The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
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Interaction Leads engagement with internal key stakeholders (e.g. Global Medical Affairs, MCE, Region/LOCs, MPD, Global Outcomes Research and Epidemiology [GEO], and Publications) as needed. Job Description Objectives: The Associate Director, Global Scientific Communications, Mature Brands, is a dynamic, strategic role within Global Medical Affairs that collaborates with cross-functional partners to own one or more disease areas / assets on a Global level.
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VetsEZ is seeking a VistA MUMPS Expert to support a Department of Veterans Affairs project. Experience with VistA options, keys, tokens, OAuth Scopes, and IAM. Proficiency in DevSecOps, CI/CD, Infrastructure as Code, and automated testing.
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10 years of relevant professional experience, including at least 3 years in Regulatory Affairs in a U.S. advertising and promotion role. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s.
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The primary function of the Associate Director/Director of Biologics CMC Regulatory Affairs is leading the development and implementation of biologics CMC global regulatory strategies for FDA, USDA and other agency regulated programs in development and registration preparation for biologics animal health pipeline programs.
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Job Requirements REQUIRED: bachelor’s degree with coursework in public policy, public administration, international development, international affairs, economics, or a related field; at least four years of relevant work experience; and demonstrated academic interest in rigorous evidence about poverty alleviation.
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Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs. Exclusive preferred pricing on Peloton fitness equipment.
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Build strong relationships with Student Affairs, Residence Life, Student Athlete Advisory Committee, Undergraduate Student Government, and the Campus Activity Board. Proven experience with the following applications and web development software: Adobe Premiere and PhotoShop, Adobe Illustrator, Microsoft Excel, Motion Graphics, Adobe InDesign, Javascript, HTML.
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We’re hiring for a Government Affairs Manager who will be responsible for implementing strategies to advance the company’s legislative and political agenda. We’re hiring for a Government Affairs Manager who will be responsible for implementing strategies to advance the company’s legislative and political agenda.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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affairs job in Needham, MA
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