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The SS&C team conducts descriptive research, medical chart review validations, and pragmatic research using the FDA Sentinel Common Data Model (SCDM), Sentinel and Distributed Research Network (DRN) tools, Observational Medical Outcomes Partnership (OMOP) CDM, Patient-Centered Outcomes Research Initiative (PCORI) CDM, and Aetna’s Enterprise Data Warehouse (EDW.
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Working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and scientific expertise in the assigned area is required along with familiarity of all applicable federal and state regulations and institutional policies.
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Strong expertise in analyzing next-generation sequencing (NGS) data and multi-omics data integration. Ph. D. in Genetics, Bioinformatics, Computational Biology, or a related field. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.
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Knowledge of FDA regulations and guidelines for pharmaceutical marketing. We are seeking a highly motivated and experienced Pharmaceutical Marketing Associate to join our team. Job Description Description: Job Title: Pharmaceutical Marketing Associate.
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Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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Regulatory Compliance - Ensure compliance with VA and regulatory standards pertaining to medical equipment and clinical systems including those from VHA's Office of Healthcare Technology Management (HTM), The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), and others.
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Experience participating and providing support during third party audits such as BSI, FDA, others. Familiarity with ISO and FDA requirements on Design Controls and CAPA Methodologies. A minimum of 3 years of experience working within FDA regulated environment, preferably in the IVD or medical device manufacturing space.
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Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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Ability to understand, assess and communicate FDA regulations. Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals.
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Lead migrating on-premise data to AWS cloud, ensuring compliance with pharmaceutical industry standards (e.g., HIPAA, FDA). PostgreSQL , MySQL, Aurora, RDS/ Document DB/ Redshift, etc. AWS Certification, such as AWS Certified Solutions Architect or Data Analytics.
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Prepare or coordinate the preparation of Q-submissions, 510(k) and/or PMA submissions to FDA. Seek input from outside consultants and regulatory attorneys to define and confirm potential pathways with FDA.
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Administer Clinical Laboratory Improvement Amendments (CLIA)-waived rapid HIV and Hepatitis C screenings and addition to screenings for sexual transmitted infections (STI) through venipuncture blood draws and/or urine collection methods to ensure that the department is in compliance with the FDA requirements and restrictions for conducting rapid testing.
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While prior knowledge is always a plus, we are happy to provide thorough training on OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration), and FSMA (Food Safety Modernization Act) regulations.
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Minimum 3 years’ experience as a Software QA Lead, in an FDA (or similarly regulated) environment such as a Medical device, Pharma or Biotech domains. Strong familiarity with applicable regulations and standards including relevant FDA, CLIA, ICCBBA, AABB, FACT, ISCT, ISO and similar requirements.
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Experience in the drug/device combination product regulatory framework (FDA, MDR, etc) Our advanced drug delivery solutions (ADDS) include well known products such as the BD PhysioJect autoinjector, the BD Vystra multidose pen, the Libertas Wearable Injector, and the Evolve On-Body Injector.
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