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Director, Clinical Outcome Assessments (COA) And Value & Real World Evidence (VRWE) Study Management
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Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
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Pharmacy - This team generates health economics and outcomes research evidence in diverse disease states and therapeutic areas to support various internal pharmacy business units such as clinical formulary strategy, specialty strategy, pipeline and trend, patient safety & quality, clinical programs and pharmaceutical manufacturer relations.
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Familiarity with areas of scientific knowledge relevant to pharmacopeial work including biologic drugs, excipients, active pharmaceutical ingredients, dietary supplements, analytical and pharmaceutical manufacturing instrumentation, quality control, regulatory science, basic statistics, metrology.
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Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and ODH, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities.
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Senior Research Analysts, Psychometrics, in the Patient Centered Outcomes (PCO) team, are essential contributors working across a range of projects which are conducted for our pharmaceutical clients, primarily.
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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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BS in Bio/Chem Engineering, Biology, Chemistry, Pharmaceutical Science, Biochemistry, biophysics, Molecular Biology, Life Sciences, vaccine development, or a related scientific discipline with 3 plus years of experience, MS degree with 1 plus years of experience in pharmaceutical or biotech companies, or PhD with relevant experience.
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0-2+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
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PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
$101,383 - $124,846 a yearFull-timeExpandUpdated 2 days ago - UpvoteDownvoteShare Job
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Eight (8) years of relevant work experience in life sciences (eg biotechnology or pharmaceutical industry, research laboratories, contract research organizations), preferably with experience in drug development and oncology, including prior management of preclinical/research focused development efforts.
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Experience with pharmaceutical drug development and Medical/Scientific Affairs. Thorough understanding of drug development and pharmaceutical market support and in-depth knowledge of Hematology/Oncology (clinical evidence and real-world patient management.
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PhD in Bio/Chem Engineering, Biology, Chemistry, Pharmaceutical Science, Biochemistry, biophysics, Molecular Biology, Life Sciences, vaccine development, or a related scientific discipline with 5 plus years of experience, or MS degree with 7 plus years of experience in pharmaceutical or biotech companies.
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6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation. 6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation.
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Minimum 3-5 years clinical experience in any of these areas: acute care, home health, physician office management, managed care organization, provider relations, pharmaceutical sales. Minimum 3-5 years clinical experience in any of these areas: acute care, home health, physician office management, managed care organization, provider relations, pharmaceutical sales.
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Overview : The QA/QC Analyst at AstraZeneca is likely responsible for ensuring the quality and compliance of products and processes within the company's pharmaceutical manufacturing or research facilities.
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pharmaceutical job Company: Ppd in Rockville, MD
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