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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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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.
$88,500 - $149,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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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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Director, US Medical Affairs Excellence Psychiatry will serve as the external engagements, insights, and scientific communications & training lead for the Psychiatry Medical Affairs therapeutic area.
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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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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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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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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.
$143,300 - $286,700 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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This role will report to the Sr. Director, Global Strategic Marketing in our Lake Forest, IL location. 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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The Sr. IT Audit Consultant will lead and execute IT, Privacy, Device Security, Operational and Integrated audits throughout Baxter’s international and domestic organizations. Sr. Audit Consultants are expected to travel 15-25%, including international travel.
$88,000 - $121,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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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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regulatory affairs jobs Title: sr regulatory affairs associate Company: Cardinal Health in Northbrook, IL
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