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Knowledge of regulatory requirements related to clinical pharmacology, M&S, and drug development and record of contribution to INDs, CTAs, CSRs, NDAs, and MAAs as well as experience with regulatory agency interactions.
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The Hematology Research and Development (R&D) team is accountable for all drug development activities in hematology research from first-in-man studies, all the way to late-stage trials leading to drug approval by regulatory agencies (Phase 1, 2, and 3 trials.
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Manage projects from initiation through closure for full scope regional and global projects, with activities focused on site selection, study start-up (including all systems and plan development), clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), administration of data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.
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This leader will work closely with colleagues across Pharmaceutical Development, Medicinal Chemistry, and Safety Assessment, and Regulatory CMC to drive compound selection, chemical process development, formulation development, control and stability strategies to efficiently move compounds from late discovery through preparation for phase three manufacture.
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Principal Scientist, Process Microbiologist, Manufacturing Science And Technology at LOTTE Biologics
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Knowledge of mammalian-based biologics manufacturing processes, with expertise in at least one area of drug-substance bioprocessing such as cell culture/fermentation or protein purification, as well as process development, manufacturing support, and/or protein chemistry is preferred.
$91,000 - $142,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Excellent opportunity for an experienced Method Development Staff Scientist to join our rapidly growing team in Chantilly, VA. Labcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide.
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Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
$145,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Better predictive models for use in drug discovery and development will reduce the total number of animals used in the preclinical safety and toxicology assessment phase of the development of biologics, including reducing the use of higher species, in addition to supporting earlier attrition and reduced safety complication in the clinic.
$95,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
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Solid understanding of scientific principles and regulatory requirements relevant to global drug and drug-device combination product development, registration and post-market support.
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Responsibilities Establish and continuously optimize overall BSM processes across PrM. Support development of a strategy, including QCP, TS and CDx, and process to construct and execute plan document such as Pharmacokinetics (PK), Anti-Drug Antibody (ADA) and biomarker analysis plans, which aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents.
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In order to be considered for this position candidates are required to submit an application for employment through our career site, be at least 18 years or age, willing to take a drug test, submit to a background investigation as part of the selection process, as well as additional periodic background checks as required by the Chemical Facility Anti-Terrorism Standards (CFATS) or regulations adopted by the Department of Homeland Security or other regulatory agencies.
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Solid understanding of the biotech industry, including, but not limited to, chemistry and biology fundamentals, the drug development process, the U.S. healthcare and regulatory landscape, and venture and equity financing.
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Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process. Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage.
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The increasing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization.
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