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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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We at the School of Public and International Affairs believe that it is vital to cultivate an environment that embraces and promotes diversity, equity and inclusion - fundamental to the success of our education and research mission.
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Interacts internally with Strategic Pricing & Contracting, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting Strategy colleagues across all franchises, and all others, including global colleagues/counterparts, on a routine basis.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Identify develop operational institutional pathways to grow scientific engagements research and data for the enterprise with a special focus on community oncology centers and accounts for ongoing working groups and consortium support Contributes to the scientific affairs HCE partnership execution with select external research partners to maximize effective and compliant delivery of research with external organizations.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
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Publish, review, submission and archival of assigned global eCTDs and paper submissions using Regulatory Affairs systems/tool. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool.
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The Associate will leverage a variety of analytics and visualization techniques to contribute to research, clinical development, drug safety and post-marketing activities.
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About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions that drive patient access to innovative products.
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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Ideally 1 year in regulatory affairs or 2-3 years in a complementary functional area (eg, clinical research) Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary.
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Proven track record of successful public relations/communications, corporate communications, product communications, public affairs, and/or media relations achievements is required. We are seeking a proactive and strategic Senior Manager of Communications and Public Affairs (C&PA) to be part of an agile communications team approach.
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affairs job Company: Biophase in Princeton, NJ
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