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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Supervise and support reporting units, including Communications, Legislative Affairs, Constituent Services, Hiring and Staffing (Human Resources Liaison office), Federal Policy, Member Engagement, Housing and Homelessness Policy, and MassHealth’s Project Management Office.
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Description Objectives: The Associate Director, Global Scientific Communications, Mature Brands, is a dynamic, strategic role within Global Medical Affairs that collaborates with cross-functional partners to own one or more disease areas / assets on a Global level.
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Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
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Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices.
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Enforce the rules of the university by working in partnership with the Dean of Student Affairs Office and provide written and oral documentation of violations. The Tufts University Department of Public Safety is comprised of fully sworn and certified police officers, campus security officers, dispatchers, emergency management, fire safety, crisis intervention, threat assessment staff and a student run EMS service.
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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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Join Takeda as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda.
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Additional information about the portfolio of the Associate Provost for Graduate Affairs can be found at:. The Associate Provost for Graduate Affairs is the senior officer with responsibility for assuring that BU provides a high-quality graduate education and a supportive environment for our graduate students that is aligned with the aspirational goals in the University's strategic plan.
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Lead and synchronize a cross-functional team, including R&D, regulatory affairs, CMC, commercial, and finance to align with program objectives. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Collaborate with Medical Affairs, Clinical Operations, and other relevant internal stakeholders, and serve as a Company resource to external stakeholders. Serving as a field-based extension of Medical Affairs, the Medical Science Liaison (MSL) will represent the Company, a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies that target p53 mutations.
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The Clinical Affairs Specialist, MCS augments the sales process for the Teleflex Intra-Aortic Balloon Pump (IABP) by partnering with sales representatives and the current or intended customer to drive the clinical aspects of product evaluations, installations, and post-installation training needs to advance and/or maintain stages within the product adoption cycle.
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Collaborates with External Affairs to develop and carry out marketing and/or public relations programs to enhance the Medical Center’s image within relevant healthcare communities as a surgical services provider of choice.
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affairs job Title: director clinical assoc in Waltham, MA
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