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3+ years as a Pharmaceutical Sales Manager with successful track record of driving salesresults within a specific region while leading a team of pharmaceutical salesrepresentatives. TARPEYO andKINPEYGO are the first and only treatments approved for IgA nephropathy by the FDA and EMA, respectively.
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Analyzes the benefits and risk aspects of an assigned therapeutic candidate: Responsible for the analysis of clinical data, including safety monitoring, responsible for activities and procedures that ensure patient safety, ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
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Must be comfortable making presentations in team meetings and must have the ability to communicate complex technical information clearly and conciselyGood project management and leadership skills, with ability to lead multiple programs at the same timeEnjoy working in a fast-paced environment within a matrix organizationPreferred Education and Experience:PhD in Pharmaceutical Sciences or relevant technical field with 6-8 years experience or MS with 10+ years experience.
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As a Manager Trainee - Quality with BioLife Plasma Services, a subsidiary of global leader Takeda Pharmaceutical Company, you will learn and work in a structured management training program. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
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Document control, archive, archival, archivist, doc control, qa, quality assurance, quality associate, quality specialist, quality assurance specialist, gmp, cgmp, gxp, mastercontrol, veeva vault, edms, document management system, pharma, biopharma, medical device, biotech, biotechnology, fda, quality systems, qms, eqms, clinical manufacturing, commercial manufacturing, novel pharmaceutical, novel drug, novel therapeutic.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.
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You'll build leadership skills that set you up for future growth, while receiving step-by-step training on how to rigorously monitor quality at our plasma centers. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated, and enthusiastic to join our team. Responsible for providing facility/equipment cleaning, and sanitation, in support of FDA regulated manufacturing areas.
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Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; and relevant Fareva SOPs. MS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline 6 years of relevant Quality experience preferably in the /pharmaceutical industry.
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Knowledge of FDA regulations and pharmaceutical processes a plus. Registered Nurse with 3 years of experience working in a hospital in patient setting or 3 years pharmaceutical experience.
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Education: Minimum Bachelor's degree required with focus in the area of chemistry, biology or related science Licenses/ Certifications: Regulatory Affairs Certification (RAC Drugs) preferred Experience: At least 5 years’ pharmaceutical or biologics CMC submissions experience with FDA required.
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Performs basic preparatory procedures on feed samples containing pharmaceutical ingredients according to FDA cGMP requirements. 75% Grinds feed mill samples and prepares fecal and gut samples as part of routine testing programs.
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This position is for a major pharmaceutical company , and this position is a suitable for someone with an associate or bachelor's degree, with 2-5 years of experience in calibration, maintenance, repair, and performance verification work.
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Experience in Pharmaceutical, Chemical, or related regulated industry such as cGMP, ISO or FDA preferred. Experience in Pharmaceutical, Chemical, or related regulated industry such as cGMP, ISO or FDA preferred.
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Stay updated on relevant laws, regulations, and industry standards to ensure compliance with 503B, DEA, BOP, DHHS, FDA guidelines. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide.
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