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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Genitourinary Clinical Research Program [TNA.
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The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Provide thought leadership in partnership with Government Affairs to advocate on behalf of Fidelity and its customers.
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Contribute to the writing and/or review of scientific communications, inclusive of patents, publications, and regulatory filings. Perform bioanalytical assays to characterize cellular phenotypes (flow cytometry, immunocytochemistry, Western Blot, qPCR, ELISA.
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Build and cultivate working relationships across internal stakeholders (Medical Affairs colleagues, Clinical Operations, HEOR, R&D, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements.
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Develop and maintain strong working relationships with a range of stakeholders including research scientists, statistical programmers, scientific communications, research oncology and regulatory affairs.
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Give to the continuous evolution of the end-to-end Compliance Program, including regulatory change management, policies and procedures, risk assessments, regulatory exam and issue management, compliance training and third-party risk management.
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He was vice president for university relations at Cornell University and held senior public affairs positions at the University of Illinois, and Stony Brook University. He spent 40 years in higher education, 17 as the senior vice president for public affairs and government relations at Duke University where he served three presidents.
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Regulatory Compliance: Ensure that all assay development activities adhere to relevant regulatory standards and guidelines, including but not limited to FDA, ISO, and CLIA. We are supported in this mission by top Silicon Valley and New York venture firms that are leaders in the healthcare space with extensive experience in supporting precision medicine companies such as Foundation Medicine and Guardant Health.
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Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems. Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
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BioCryst Pharmaceuticals is seeking an experienced Medical Science Liaison (MSL) to join our US Medical Affairs team. As a field-based MSL you will be a true scientific, medical expert and an extension of BioCryst Medical Affairs.
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This individual is responsible for working with partners to understand their objectives and customer messaging requirements, develop contact lists, and ensure the timely, flawless delivery of marketing, service, and regulatory communications to WI customers.
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The candidate will work with a large and extended Cyber Platform operations team and provide a variety of network & Perimeter Security expertise, Candidate will play role as People manager and work as SME for Advance security expertise for Fireeye, IDS/IPS, Email Security, Cloud Security - Perimeter Security, Splunk, and WAF operations.
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regulatory affairs jobs Title: sr regulatory affairs associate in Durham, NC
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