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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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This is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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Previous experience or exposure to regulatory, government, or external affairs. And our Water Quality companies-Aquatic Informatics, ChemTreat, Hach, McCrometer, OTT HydroMet, Sea-Bird Scientific, Trojan Technologies, and XOS-help customers manage, treat, purify, and protect the global water supply, from municipal and wastewater treatment facilities to lakes, rivers, watersheds, and oceans.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist or clinical laboratory scientist.
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Team Development: Build and lead an empowered team of quality and regulatory experts, overseeing tools, business processes, and procedures supporting cell-based bioassay, cell & gene therapy, and virology testing.
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Serves as the principal liaison to other MGB and Mass General hospital departments and services such as: Patient Care Services; Network Development; Marketing; Office of General Counsel; Development; Public Affairs and Communications; Research Management; Budget and Finance, etc.
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Under the direction of the Division of Academic Affairs, the Speech Language Pathologist (SLP) / SAIL Program Coordinator will facilitate programs and activities for students and families enrolled in our Social Assistance in Learning (SAIL) Program.
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Under the direction of the Hospital Coding Manager or Supervisor, and exercising independent judgment within the scope of the job, the Hospital Inpatient Coder II assigns applicable ICD-10 Codes, Present on Admission (POA), Hospital Acquired Condition (HAC), and Patient Safety Indicators (PSI) using current industry standards, the Official Coding Guidelines, Coding Clinic, UHDDS and regulatory requirements.
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Territory Includes: MA, CT, NJ, NY, PA, MD, DC, PA, OH, MI, IN, IL, WI, MNServing as a field-based extension of the Company’s Medical Affairs team, the Medical Science Liaison (MSL) will represent the Company as a part of the Nephrology Medical Affairs team.
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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Strong technical writing, strong GMP documentation, strong understanding of assay validation under GMP compliance with regulatory requirements, late stage/commercial stage assay development and validation, life cycle management.
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Serve as cross-functional strategic leader on all Medical and Clinical work streams in the oncology portfolio, including clinical pharmacology, statistics, clinical operations, regulatory affairs, and preclinical science and translational medicine.
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Reporting to the Associate Dean of Students in the Division of Student Affairs, the inaugural Director of LGBTQIA+ Student Resource Center ("Center") will be charged with laying the foundation for and ensuring the immediate and ongoing success of the new Center at Boston University.
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The person will work directly with stakeholders across – ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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The Sr MSL will contribute to shaping the medical plan by providing external stakeholders' insights and contributing to the designing and execution of the Medical Affairs strategy and plan.
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regulatory affairs jobs Title: sr regulatory affairs associate in Brookline, MA
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