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Assists the Assistant Dean of Student Affairs in determining resource allocation, including budgets and staffing, for student programs, organizations, and events. Essential Duties and Responsibilities: Under the direction of the Assistant Dean for Student Affairs, do the following: A. Guide to Professional Success (GPS) –Scheduling - Oversees and manages GPS CalendarSchedules rooms and appropriate educational technology support for GPS sessions Communication - Manages GPS communication Ensures timely and effective correspondence with session presenters, learning community mentors, and students via email, news board, and student assignments.
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Establish relationships with peers in key functions including MAM, Asset Strategy Leads, Pipeline Commercial Strategy, HEOR, Market Analytics and Insights, US Pricing, International Market Access and US Government Affairs, US Public Affairs, and US Medical Affairs.
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This includes the management and preparation of various critical regulatory documents such as: product Safety Data Sheets, product labels, product attestation documents and certifications. Required Knowledge: Regulatory, Scientific/Technical, QA, Business acumen.
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This position serves and provides direct support to the ID DVP Global R&D, DVP Global Regulatory Affairs, DVP Global Medical and Scientific Affairs, and to the Director, Portfolio Strategy and NPI Program Management Office.
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Provide real-time decision support via close coordination and collaboration across multiple stakeholders within PCS and other AbbVie partners including US Commercial & Finance, R&D, Decision Sciences, Marketing Analytics & Business Insights, HEOR, Global Epidemiology, Global and US Market Access and Pricing, Finance, Regulatory, Medical, Global Marketing & Commercial Operations, and Area & Affiliate Commercial organizations.
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Partner with cross-functional groups (Brand Marketing, Legal, Regulatory, Medical, Sales, Sales Training, Consumer Marketing, Market Analytics and Business Insights, Finance, HR, OEC, etc.) to ensure integration and consistency of professional business strategies and regulatory compliance of promotional materials.
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We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
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The position will report directly to the Laboratory Director and work alongside technical staff specialized in fields of analytical, toxicology, and regulatory affairs as well as other labs and functions.
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Provide overall oversight of school to ensure adherence with the Federal Head Start Program Performance Standards, ISBE Preschool for All/Prevention Initiative requirements, DCFS licensing guidelines, Start Early policies and procedures, and mandates from all funders and regulatory agencies.
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The applicant is expected to develop highly effective collaborations with relevant stakeholders including those in Patient Health & Impact, the Patient-Centered Outcomes Assessment Group, Statistics, Clinical Pharmacology, Clinical Development, Medical Affairs, Epidemiology, Programming, and other groups contributing to HEOR analysis and strategy.
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Manage regulatory analysis program by organizing, performing and recording quarterly and annual testing. Organize and participate in periodic regulatory strategy meetings with business units.
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Meets regularly with the CMS Assistant Dean of Student Affairs and Learning Community Advisors to strategize support for students in need of additional academic, professional, wellness, and/or career support.
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Performs imaging procedures in accordance with radiation safety practices as determined by Illinois Dept. of Nuclear Safety and Nuclear Regulatory Commission to limit radiation exposure to patient,self and other healthcare team members.
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Ensures that reports are completed and submitted on time to Start Early, funders, and regulatory agencies and that goals, objectives, and activities are tracked. Deep commitment in advancing diversity, racial equity, and inclusion into organizational routines and practice.
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Cell Therapy functions (CT Manufacturing Operations, Product Operations, Quality Assurance, Quality Control, CT Development, MSAT, Supply Chain, Finance, Regulatory, etc.) Broad technical expertise with biologics or cell therapy commercial manufacturing & analytical processes, technology transfer and/or start-up phase experience highly desired.
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regulatory affairs jobs Title: regulatory assistant Company: Jobget in North Chicago, IL
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