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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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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. Veralto is looking for a Director of Strategic Development to contribute to the corporate strategic direction for the new ~$5B enterprise.
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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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Regularly briefs Academic Affairs, Director of PAL, Residential Life, Student Affairs, Office of Disability Services (ODS), and Counseling Center on social learning issues; 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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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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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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Alexion, AstraZeneca Rare Disease is seeking a highly motivated co-op with educational experience in Regulatory Affairs. This co-op student will be a member of and support regulatory subteam activities and work on a variety of projects across Regulatory Affairs (RA) including Development Strategy, Established Products, Labeling, Operations, CMC, Advertising & Promotion, and Clinical Trial Excellence.
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The director will partner broadly with campus constituents such as but not limited to Development/Alumni Relations, LGBTQIA+ Center for Faculty & Staff, Residence Life/Housing, Student Activities, Howard Thurman Center for Common Ground, Student Health Services, Community & Inclusion, Government/Community Affairs, the Newbury Center, International Students and Scholars Office, and Athletics.
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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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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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Director, Global Regulatory Affairs, Development Strategy. 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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In collaboration with the Associate Chief Nurse, the Nursing Director plans, organizes, implements and oversees clinical and program development in the assigned area(s) to contribute to meeting the mission and goals of Brigham & Women’s Faulkner Hospital as well as the regulatory requirements of the JCAHO and other applicable federal, state and local regulatory or accrediting agencies.
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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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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents.
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regulatory affairs jobs Title: sr director Company: Merck in Cambridge, MA
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