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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiations.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization.
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Work on issues related to Medicare coverage determinations, Medicaid coverage and preferred drug list determinations, FDA drug development and safety policies, agency guidance policies related to patient engagement and diversity equity and inclusion (DEI) impacting health access, clinical trials, and research opportunities.
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At least 5 years of on-going clinical trials experience in the pharmaceutical or device industry. Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.
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Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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The Center for Cancer Cell Therapy (CCT) at Stanford University is seeking a Clinical Trials Regulatory Specialist 2 to be responsible for the administration and regulatory compliance of clinical research within the university and representing the university with external regulatory agencies, both domestic and international.
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The individual will also contribute to the overall CMC strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in CDMO management for other CMC areas including analytical and drug product.
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Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. 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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Essential Functions Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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Statistical Programmer, clinical trials, SAS. Provide Statistical Programming support in producing or verifying SAS scripts and outputs for Analysis Files, Tables, Listings, Figures, and any other form of Clinical Trials.
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The iBAM staff currently includes ~100 members ranging from undergraduates to senior level Research Assistant Professors and supports research ranging from chemistry, to genetics, bioinformatics, and clinical trials.
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