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Partner closely with business functions including Commercial, Medical Affairs, Public Affairs, Government Affairs, Finance and Clinical (amongst others), and other teams as part of the OEC and Legal organizations to address ethics & healthcare compliance policy-related issues.
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Student Affairs, academic or work experience related to the fields of social work, community organizing, arts & media organization, student affairs, counseling psychology, race & ethnic studies.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Senior Regulatory Affairs Specialist, Redwood City, CA - Develop strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate approval with global regulatory agencies.
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SLAC National Accelerator Laboratory’s Office of Strategic Communications & External Affairs (SC&EA) is seeking an experienced Media Relations Lead to join the External Communications team. The Media Relations Lead will promote SLAC’s initiatives, research and people by writing, editing and distributing impactful press releases, crafting compelling media pitches, and organizing media events at SLAC. The Media Relations Lead will provide media training to SLAC staff and demonstrate critical leadership in dealing with sensitive media issues and crisis communications.
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Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Clinical Research, Patient Safety, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
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Partner with other teams involved in the end-to-end assay launch and maintenance processes, including Clinical Ops, Clinical Lab, Quality, Regulatory Affairs, Medical, Business Stakeholders, etc.
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Works collaboratively with others in biometrics (e.g., statistical programmers) as well as with other functional groups such as clinicians, medical and scientific affairs colleagues. Expertise in statistical methods to support medical and scientific affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials.
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As a member of a cross-functional team, GRAIL’s Principal Scientist, RWE will build and maintain cross-functional relationships with Medical Affairs, Clinical Development, Regulatory, and business teams; and collaborate with the team effectively to ensure the implementation of rigorous methods and delivery of scientifically sound results, in support of regulatory submissions, publications and/or other uses.
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The food program director and the director of operations - including buildings and grounds, transportation, events & rentals, and summer programs - report to the CFO, who retains responsibility for legal affairs, compliance, and risk management.
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Closely collaborates with various internal stakeholders such as Clinical Operations, Clinical Sciences, Regulatory Affairs, Biostatistics, Data Management, and Project Management, as well as external partners to ensure execution of pharmacovigilance activities in accordance with relevant regulatory requirements.
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Superior knowledge of industry regulations and operational guidelines; specific knowledge of industry trends in Clinical Development, Regulatory Affairs, and GMP/GCP/GLP compliance is a plus.
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About Stanford University's Hoover Institution: The Hoover Institution on War, Revolution, and Peace is a public policy research center devoted to the advanced study of economics, politics, history, and political economy—both domestic and foreign—as well as international affairs.
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Collaborate with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle. - Define project requirements, specifications, and timelines in collaboration with cross-functional teams, including engineers, researchers, medical professionals, and regulatory specialists.
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affairs job Title: sr regulatory affairs Company: Cardinal Health in Belmont, CA
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