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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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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.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Discuss strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development, including clinical development plan and regulatory submission strategy.
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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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Diversify your industry experience by working on a plethora of various industries including private equity, healthcare, tech, financial products, oil & gas, green energy, real estate, consumer products, and other various industries.
$175,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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These range from incubator companies focused on technology and cutting-edge diagnostics, to Fortune 500 entertainment, pharmaceutical, consumer products, publishing, consulting, manufacturing, and financial services firms.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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Collaborates cross functionally with Product Management, Consumer and Clinical Sales, Marketing, Business Intelligence, etc. This includes the software engineering of products and business systems, BI data, and IT. The Head of Technology is a member of the LG Executive Team and partners with leaders to create and execute the company’s strategic plan and develop the vision for the product to help us realize our mission.
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Align and collaborate with BMS Site Management, Corporate Affairs, Tax, Treasury and Legal to ensure acceptable outcomes. Implement Strategies through efficient use of Service Providers (Brokers, Lawyers, Land Design Firms, and Planners) and Collaboration with Internal Resources such as Finance, Facilities, Legal, Procurement, Engineering, and Corporate Affairs.
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As a visible RWE/D champion within the US organization, will interact with a wide number of NNI stakeholders across not only Clinical Data Science and Evidence (CDSE) but more broadly within Clinical, Medical and Regulatory, Market Access and Public Affairs, as well as collaborating where appropriate with therapeutically aligned global counterparts in Epidemiology, Data Science and Global Evidence and Pricing Access.
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Develop, maintain and execute Global Publication Plan (GPP) in collaboration with Clinical Research, Commercial, HEOR, and Medical Affairs. Develop, maintain and execute Global Publication Plan (GPP) in collaboration with Clinical Research, Commercial, HEOR, and Medical Affairs.
$226,900 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis SOPs and US as well as global regulatory and compliance rules/law.
$400,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The deadline for receipt of complete applications is November 4, 4, at : p.m. EST. 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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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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consumer affairs jobs Title: regulatory affairs in Princeton, Anoka, Minnesota
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