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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 Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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Expert in GCDMP, CDISC standards, regulatory compliance (21 CFR Part 11, GDPR), and proficient in MedDRA and WHO-Drug coding, ensuring adherence to ICH GCP and industry standards. Oversee the development and testing of clinical databases and data cleaning procedures, utilizing Medidata Rave/Veeva, and enforce data integrity through comprehensive documentation and quality control.
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Ensure robustness, reproducibility, and regulatory compliance of biomarker assays and data generated across clinical studies. Strong knowledge of biomarker technologies and methodologies, including genomics, proteomics, imaging, and flow cytometry, as applied to clinical research.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing and analytical requirements.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws.
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Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment.
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This role will provide short- and long-term strategic leadership of safety surveillance for Dyne's clinical development programs, including resource planning and long-range capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management.
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They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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The Clinical Research Associate (CRA) will oversee the day-to-day operations of investigational site activities in a global pivotal trial. Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification) preferred.
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This position reports to the Executive Director of MSLs. The MSL will have contact with internal colleagues in compliance, regulatory, pharmacovigilance, marketing, sales, research and development, medical science, medical information, market access, training, strategy and portfolio management, and HOVA. This internal collaboration is considered a fundamental and essential part of the position.
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The Clinical Research Coordinator, Level 1 (CRC1) is a research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities.
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clinical research pharmaceutical company regulatory compliance jobs Title: senior director in Waltham, MA
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