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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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NAGPRA Registrar (9722C), Government & Community Affairs - 67034 About Berkeley At the University of California, Berkeley, we are committed to creating a community that fosters equity of experience and opportunity, and ensures that students, faculty, and staff of all backgrounds feel safe, welcome and included.
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Essential Job Functions:Provides strategic advice on complex reporting and technological issues raised by the MRTS business units, Regulatory Services Management (“RSM”) team, Regulatory Operations teams, and other FINRA customers, as applicable.
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Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine and development operations.
$161,600 - $269,400 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. Associate Director - 5 – 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
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The Director of External Affairs advises OEWD’s Leadership team on strategic communications, and reports to the Chief Operating Officer. A Director of External Affairs for the Office of Economic and Workforce Development who is responsible for the overall direction and management of communications and community outreach and engagement.
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Lead statistical programming activities for regulatory submissions following CDISC standards. Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
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Position Summary:Reporting to the Senior Vice President, Medical Affairs, we seek an experienced, science-focused, MSL to join our rapidly growing medical affairs team with the primary mission of increasing awareness with regards to the unmet need and pathogenesis of IgAN, and the role of targeting BAFF and APRIL as a potentially transformative, disease-modifying therapy.
$202,000 - $226,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Sr. CTM/CTM will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, QA, Regulatory Affairs and Project Management to ensure study team goals are met.
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Identify the need to conduct CEQA/NEPA reviews on projects, acquire environmental resource discretionary permits, complete the application process and negotiate the terms of such permits with the regulatory and land management agencies.
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Works collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
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The division of Medical Education within the UC San Diego School of Medicine consists of the following units: Undergraduate Medical Education, Admissions & Student Affairs, Diversity and Community Partnerships, Graduate Medical Education, Continuing Medical Education & Faculty Development, Simulation Education, Physician Assistant Education, Anatomical Services, Business Affairs and Educational Technology.
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What you’ll be responsible for:As a member of the Data Engineering - Business ETL team, you own the ETL/ELT pipelines and data warehouse that is used for financial and regulatory reporting. Working closely with across groups, such as the product, engineering, data science, compliance, and security teams, for data modeling, general management of data life cycle, data governance and processes for meeting regulatory and legal requirements.
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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
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regulatory affairs jobs Title: sr regulatory affairs associate in San Francisco, CA
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