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Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development.
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Oversight of P2P activities for all projects for assigned TA and/or Function, including contract review and execution in alignment with Alexion policies. 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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In addition, the Associate Director will provide essential medical and scientific expertise, review, advisement and oversight to support development of high quality promotional and medical materials, internal training materials, and communications as part of the Promotional Review Committee (PRC) and Medical Review Committee (MRC.
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The position will work with investigators, the General Counsel’s Office, the Clinical Trials Office, the Technology Ventures Office, Institutional Review Board, and other institutional offices to oversee the negotiation of Subcontracts, Clinical Trial Agreements, Data Use Agreements, Billing Agreements, and other atypical agreements.
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Role and Responsibilities:The ESP Senior Medical Director provides leadership and management for the clinical staff of the Elder Service Plan - Program for All Inclusive Care for the Elderly (PACE) Centers as well as provides primary care, including routine health maintenance, management of chronic conditions, and management of acute illnesses.
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The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.
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The Associate Director of US Medical Review leads the Medical Review as part of the MLR team. Representing medical function in the Medical & Promotional Review Committees and ensures scientific / medical / clinical accuracy, relevance and completeness of data and that promotional claims within materials are adequately supported by data.
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Reporting to the Head of Safety, the Senior Medical Director, Drug Safety will lead pharmacovigilance activities including the analysis of safety data, identifying, detecting and investigating safety signals, evaluating and proactively managing risk, and providing medical safety review of Dianthus products.
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This is what you will do: The Associate Director of US Medical Review leads the Medical Review as part of the MLR team. You will be responsible for: Representing medical function in the Medical & Promotional Review Committees and ensures scientific / medical / clinical accuracy, relevance and completeness of data and that promotional claims within materials are adequately supported by data.
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Provide medical expertise and review of global HEOR materials. Support Global Medical Education initiatives (concept, review etc) Cross-functional point of escalation for deliverables requiring medical review.
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Regularly meet with naviHealth’s leadership to review care coordination issues, develop collaborative intervention plans, and share ideas about network management issues. + Conduct provider telephonic review and discussion and share tools, information, and guidelines as they relate to cost-effective healthcare delivery and quality of care.
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Monogram’s innovative, in-home approach utilizes a national nephrology practice powered by a suite of technology-enabled clinical services, including case and disease management, utilization management and review, and medication therapy management services that improve health outcomes while lowering medical costs across the healthcare continuum.
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The Medical Director, working together with a coder (DRG Integrity Specialist), will review inpatient charts to ensure the acuity and complexity of the patient's hospital stay is appropriately captured in the clinical documentation and translated into coding.
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The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
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Position in this function is responsible, in part, as a member of a team of medical directors, for the overall quality, effectiveness and coordination of the medical review services.
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review job Title: medical director in Boston, MA
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