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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRCMC) Devices and Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related to Alexion’s drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products.
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The Associate Director Regulatory Affairs CMC is responsible for CMC regulatory support to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products.
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The Associate Senior Counsel position will provide strategic legal advice and counsel for a region of the Cigna US Commercial Medical Network contracting team (anticipated to be Mid-Atlantic and Liberty Valley) on a wide variety of medical provider contracting matters while working alongside the Network Regional Directors and other National Contracting leaders to support the US Medical Network business strategy.
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Internal partners include regulatory, legal, public affairs, managed care, medical and advocacy teams. The Associate Director will manage the professional marketing budget to drive the business goals for the brand in the U.S. The Associate Director must demonstrate the ability to influence and lead cross-functionally to ensure all elements of professional marketing are rooted in strategy and consistent across all touchpoints.
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This role will also work closely with global and regional (Osaka, Japan [SHQ]; Florham Park, New Jersey [SI]; and London, England [SEU/SBV]) cross-functional team members including Medical Affairs, HEOR, Clinical Development, Regulatory, Market Access, Commercial teams and external collaborators/vendors to lead and conceptualize research questions, propose study designs, identify appropriate databases, write and review protocols, oversee data analyses, reports, presentations, and publications.
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Description Summary: Reporting directly to the Vice President and Chief Human Resources Officer (VP/CHRO), the Associate Vice President, Total Rewards and HR Operations will be responsible for leading comprehensive strategy for the University’s Total Rewards programs and initiatives in support of Pace University's objectives and in alignment with the goal of attracting and retaining top talent.
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Ensure cross-functional execution of health system segment strategy with US key stakeholders, including sales, brand marketing, customer operations, market access, medical affairs, policy, communications, Health Economics, regulatory, legal, and compliance.
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These activities will be performed in cross-functional collaboration with a range of partners throughout the organization, including the US Market Access, US Medical Affairs, Medical Outcomes Science Liaison (MOSL), Public Policy & Government Relations, and US Regulatory Affairs teams.
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Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement.
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Contribute drug product expertise in support of global CMC regulatory strategy, Experience working cross functionally with greater CMC/Technical Operations team, Quality Assurance and Regulatory Affairs.
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They are seeking a Regulatory Affairs Strategy Director or Associate Director who can develop and execute global regulatory strategy plans for their clinical-stage ophthalmology programs.
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You will work closely with colleagues across External Affairs, CF, SBB, and Capital One, and with external partners to cultivate and maintain relationships, as well as to drive partner understanding of and alignment with programming goals, and ensure faithful execution.
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The Senior State Policy and Regulatory Affairs Associate will support Zoox’s state policy portfolio, providing important project management, public policy analysis, and help to implement Zoox’s state policy strategy.
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The Associate Scientific Director (ASD) for the Duchenne Regulatory Science Consortium (D-RSC) will work with leadership and interdisciplinary and cross functional teams comprised of project managers, clinical, data and quantitative medicine scientists, and regulatory experts, to advance novel drug development tools to address unmet medical needs for Duchenne muscular dystrophy and other dystrophinopathies.
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