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The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
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The Director reports to the Associate Dean of Student Equity and Inclusion, within Student Affairs. Master's degree in Higher Education and Student Affairs, International Education, or related field.
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Our department works closely with Analytical Development, Operations, Regulatory Affairs, and Quality control to formulate and manufacture innovative ocular formulations. Knowledge of current regulatory guidance and experience in managing IND/IMPD filing.
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Our clients include DHS, DHA, DoS, USMC, US Army, HHS/Indian Health Service, Department of Interior, Bureau of Indian Affairs, Bureau of Indian Education, among many more. The Senior ServiceNow Engineer to support the US Army Corps of Engineers Revolutionary IT Services (USACE RITS) to manage and oversee the Configuration Management Database (CMDB) to inventory and troubleshoot existing information, as well as, mange integration and discovery processes such as generating patterns in discovery and creating or modifying new and existing patterns in Discovery.
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The College's schools, departments, and programs—with disciplines ranging from economics and history to English, urban affairs and international affairs, form an interdisciplinary group of scholars with global perspectives and a culture of inclusion.
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Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs. Working knowledge of quality systems and regulatory requirements with prior experience in preparing and defending regulatory filings.
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The Low Demand Program is a new program funded by the US Department of Veterans Affairs Grant and Per Diem (GPD) Program and commenced on October 1 st , 2020. Schedule: Monday – Friday 6pm to 10pm.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne's complex clinical supply chain and support eventual launch and commercialization efforts.
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In collaboration with the Associate Provost for Wellesley in the World advise the President, Provost, and VP/Communications and Public Affairs on the development of new partnerships or termination of existing partnerships.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Highly proficient with the following products and platforms: MS Intune, MS Azure, AWS, AD, O365, iOS, MacOS.
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Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post market surveillance. Demonstrated understanding and experience of working in the medical device industry, familiarity with product development procedures, design control documentation and FMEA, quality assurance and regulatory standards.
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Serving as a chief operating officer for External Affairs, they provide strategic planning and direction to senior leaders and department heads in creating and establishing annual budgets for Marketing & Communications, Government & Community Affairs, and Federal Relations to ensure sound and effective fiscal resource management.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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regulatory affairs jobs Title: principal consultant in Watertown, MA
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