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Work in close collaboration with the project CMC teams and related functions, including process development, analytical development, supply chain, Quality, Regulatory, DMPK, safety, and clinical and non-clinical development.
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Performs high quality DNA and RNA sequencing data generation in a timely fashion to support all R/D programs that need to take NGS approach to address biological and medical questions. We're looking for a Computational Biology Associate Scientist , working in Biotechnology/Medical Devices industry in Cambridge.
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The Field Application Scientist will be expected to develop relationships with key customers and KOLs and generate data and application notes that can be used in the sales process. We are focused on bringing to market a novel ultrasensitive immunoassay platform capable of utilizing small sample volumes with excellent data quality.
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Design, develop, and modify data infrastructure and templates to help scientist accelerate the processes of data analysis and reporting. Working knowledge of nucleic acids DNA/RNA analytical performance assessment tools: PCR, Cloning/plasmid generation and design, Quality control on DNA/RNA (capillary electrophoresis, UV quantification, Sanger sequencing, NGS.
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PhD/doctorate in environmental health, exposure assessment, data science, environmental epidemiology, exposure science, biostatistics, environmental or public policy, or related fields. They will have advanced skills in R programming or data science methods, and have demonstrated expertise in working with high dimensional spatiotemporal data.
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The Research Scientist will work on OI research projects on conceptual and research design, project management, data management, analytics, and other areas. We are seeking a Research Scientist who will work with the senior leadership team of Opportunity Insights (OI) to conduct rigorous, high-quality research on the condition and drivers of economic mobility in the US. As a member of the OI team, the Research Scientist will help us set the standard for rigorous, policy-relevant analyses using large administrative datasets to develop research that improves economic mobility.
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Communicating to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation, and data interpretation.
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Owns operational excellence – design, implement, and monitor for Drug Discovery Units and Research line functions through IT, Finance/Legal, Procurement, and Quality, Data Privacy. Chair bi-weekly global Research Operations Agility meetings that are expanded to incorporate colleagues across R&D, with a particular emphasis on fostering connections and collaborations with business partners across Takeda (DDT, Ethics & Compliance, CEI, Quality, Global Publications, etc.
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Scorpion Therapeutics is seeking a highly skilled and motivated Senior Scientist, Analytical Development to join our CMC team. Strong understanding of regulatory requirements (e.g., FDA, ICH) governing analytical development and quality control in drug development.
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The Decision Scientist will lead data analysis projects and collaborate with cross-functional teams to identify key business insights, trends and opportunities. We're dedicated to improving the quality of our product from a customer standpoint and have a true desire to enable the success of businesses, non-profit organizations, and community groups.
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Evaluate the quality of Individual Case Safety Reports (ICSRs); provide support to maintain and optimize the execution of the Quality Control Process for ICSRsLead and conduct, independently and/or collaboratively, the preparation and authoring of safety reports for assigned products, such as PADER, PSURs/PBRER, DSURs∯*∯ Facilitate signal management process for products and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
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Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
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Under the guidance of the individual's manager in the Therapeutic Area department, the individual collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed.
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The intern will contribute to general quality operations and documentation practices, such as data entry, tracking of documents, generating of metrics, and assisting in process improvement efforts.
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Quality focused, able to develop good practices, using a critical data-driven and risk management approach. The individual ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
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data scientist quality jobs in Watertown, MA
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