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Reporting to the Director of Native American and Indigenous Affairs, the Program Coordinator plays a key role in the development, implementation, and administration of university-wide Native American and Indigenous Affairs at Northwestern.
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This position reports to the General Counsel and handles projects associated with various areas of law, including commercial and consumer lending, transactional work, regulatory issues, Fintech issues, litigation (including third party litigation) management support, and bankruptcy.
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Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable. Thorough understanding of FDA/PhRMA, OIG, Health Canada/Innovative Medicines Canada, ANVISA/ANS and other guidelines as they relate to HEOR and Medical Affairs.
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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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Provide organizational leadership to support an effective Advertisement and Promotional Review system, built upon cross-functional collaboration across regulatory affairs, medical affairs, legal and compliance partners to enable the timely execution of compliant assets and programs.
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Knowledge of and experience with anti-corruption and bribery matters is required, with exposure to U.S. and foreign enforcement or regulatory agencies preferred. Experience conducting internal investigations of potential violations of legal/regulatory requirements and of corporate policies/expectations, occurring in the United States and abroad, and managing investigation workstreams, including managing internal team members and external resources (outside counsel, consultants, etc.
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6+ years of progressive medical/scientific affairs experience within the pharmaceutical, biotech industry or at a consulting firm that supports the pharmaceutical or biotech industry; at least 3 years driving medical strategy.
$280,000RemoteExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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The Director of Online Curriculum and Instruction will collaborate with administrators and faculty within Academic Affairs on the exploration and implementation of cutting-edge pedagogical approaches that enhance equity and promote student success.
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You will work across businesses and across functional groups including Global Marketing, Market Access , Research & Development, Medical & Scientific Affairs, and Finance. Thorough understanding of global guidelines as they relate to HEOR and Medical Affairs, as well as expertise in global HTA/payer reimbursement and market access requirements.
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As the head of the Rapid & Molecular Division Health Economics and Outcomes Research, you will own HEOR approach including value modeling, value-based storytelling, and value dossiers from insights to execution.
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Lead on regulatory exam management and internal audit responses. Maintenance of the third-party risk management framework and related documentation and standards, tracking and reporting on third party key risk indicators, which includes the status of SME risk assessments, issues and action plans of third-party engagements, liaising with the different SME teams and engagement owners throughout the lines of business, and training to standards and framework.
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At minimum of ten years’ experience managing teams in International Regulatory Affairs and advising manufacturers on a broad range of product regulatory affairs, and securing regulatoryapprovals from bodies such as the FDA, USDA and EFSA (European Food Safety Authority);prior experience advising industrial minerals manufacturers is very desirable.
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Lead the development of the Real World Evidence (RWE) plan in partnership with HEOR to support scientific and business strategy which is aligned to Medical Affairs Evidence Gaps; oversees generation of high quality and relevant data; provide training to key stakeholders.
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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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4) Familiarity with regulatory compliances such as REACH, RoHS, WRAS, NSF-61, and FDA. 5) Familiarity with hard coating technologies such as HVOF, CVD, and PVD. 6) Hands-on experience with chemical compatibility and corrosion assessments.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen in Northbrook, IL
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