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Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
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Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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The final candidate must successfully pass Eskaton's post offer, pre-employment testing which includes a criminal background check, drug test, COVID test, TB screen test and health screen. Supervises and directs care given to residents by Resident Care Associates, Resident Medication Assistants, Wellness Nurse, and Memory Care Coordinator (if applicable) in an appropriate manner.
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Licensed Clinical Drug and Alcohol Counselor (LCADC) is preferred. As a Director of Clinical Performance Improvement, you will oversee and maintain comprehensive and effective clinical process improvement systems for Pinnacle Treatment Services.
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Manage manufacturing activities for viral vector and cell therapy, including cGMP aseptic qualification, in support of manufacturing and formulation of viral vectors as drug substance and of cell therapeutics as drug products.
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Strengthen internal gene therapy CMC capability and serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at Adverum for its development programs.
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As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in commercial filings (BLA, MAA) and post approval changes.
$237,660 - $307,560ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents.
$180,000 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Our 2022 Annual Security Report also outlines various campus safety and security policies, such as those concerning crime reporting, prevention and response to sexual and gender violence, alcohol and drug use, crime prevention, emergency response and evacuation procedures, and other matters.
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Reporting to the Director, Project Management, the Associate Director, Project Management is responsible for managing cross-functional drug development projects, in either preclinical or clinical development stages.
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Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations. Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed's Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.
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The Director, Chemical Development & Drug Substance Manufacturing is self-motivated and demonstrates initiative in responsibilities and always strives to do the job better. Successful candidate will be passionate about synthetic chemistry, excited to solve complex problems in a fast-paced environment, and comfortable in the multidisciplinary environment of drug development research.
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This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.
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Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
$175,000 - $230,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
drug job Title: director in Redwood City, CA
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