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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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The Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives within the US Medical Affairs organization and will partner with TA Leadership teams and cross functionally to execute on projects in line with the functions overall strategic goals.
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Provides administrative support for the Associate Dean for Academic Affairs & Director of Clinical Affiliations. Provide support to Associate Dean for Academic Affairs and Director of Clinical Affiliations, as directed.
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Regulatory Affairs Expertise: Collaborate with regulatory bodies such as the FDA, EU agencies and international counterparts. Position Summary As the Vice President of Clinical Affairs, you will play a crucial role in the strategic development of our clinical research and trials.
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Provides legal support and guidance to the government affairs and funding teams, including government contracting, grant application and overbuild challenge review and drafting for the Broadband Equity, Access and Deployment (BEAD) Program and other local state and county funding programs.
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Through a comprehensive understanding of the diagnostic and care landscape, the candidate will closely collaborate with the International Business Unit (IBU) marketing and medical teams, Government Affairs, and International Communication teams to execute, in partnership with the local affiliate teams, integrated solutions designed to remove obstacles to optimal patient pathways.
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Ensure seamless coordination towards the drafting and advancement of effective federal legislation and regulations from BCBSMA to Congress and relevant federal agencies and ensure the coordinated flow of relevant legislative and regulatory information to the Vice President, State and Federal Government and Regulatory Affairs, and senior leaders including the Senior Vice President.
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Provide GCP quality support to clinical research functional areas (e.g., Clinical Development, Clinical Operations, Medical Writing, Medical Monitoring, Data Management, Biostatistics & Programming, Regulatory Affairs, Clinical Supplies Management, Pharmacovigilance.
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The U.S. MSL Team Leader will work under the guidance of the Global Head of Medical Affairs and in close collaboration with the Global Medical Affairs Leads (GMALs), EU Medical Affairs team, Clinical Operations, Clinical Development teams and Patient Advocacy.
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We are seeking a Medical Affairs Operations Manager to oversee the operational aspects of scientific communications, evidence generation and publication strategy for our portfolio of antibody therapies.
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Work collaboratively with stakeholders including but not limited to Market Access, Public Affairs, Commercial Legal, US Sales & Marketing, Global Pricing & Market Access, FP&A, Commercial Sales Operations, Accounting, etc.
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Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of new small molecule drug entities.
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Collaborate with the leaders of Academic Affairs, Student Affairs, Diversity, Equity, and Inclusion, Institutional Advancement and External Relations, and Enrollment Management among others, to secure and maximize revenues, contain costs, invest and maximize endowment funds, and plan for the resource needs of technology, finance, facilities, and capital projects.
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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. Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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About the OpportunityThe Office of External Affairs at Northeastern University is looking for a talented, hard-working, and highly motivated candidate to serve as the Executive Assistant to the Senior Vice President (SVP.
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affairs job Title: assistant Company: Citi in Cambridge, MA
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