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Head Therapeutics Counsel and will be responsible for providing legal support to business partners in various departments across the organization, such as Disease Strategy Teams, Global and North America Marketing, North America Sales, Patient Advocacy, Patient Support, Health Economics And Outcomes Research, Global Medicines Development and Medical Affairs (GMDA), Field Training, Market Research, Business Analytics, Regulatory Affairs, Public Affairs, and Corporate Communications.
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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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Act as a liaison between cross-functional teams, including clinical operations, regulatory affairs, finance, and business development, fostering strong communication and collaboration throughout the contract lifecycle.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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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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Qualifications·Demonstratedcapacityforsound legal analysis, legal reasoning, problemsolving,and legalresearch and writingskills;·Experience with administrative law, government/legislative affairs, and/or litigation;·An even temperament, principled judgment, and a positive outlook;·Strong oral and written communication skills;·Experience with Relativity eDiscovery platform a plus.
$74,818 - $109,718 a weekFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP and behavioral health, as well as the associated and relevant federal, state and local regulatory entities.
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4-5 years of experience in regulatory compliance, risk management, or audi t within the financial services industry , with a focus on IT asset management or technology controls preferred. Collaborate with Legal and Compliance teams to interpret regulatory guidance and assess the impact of regulatory changes on IT asset management practices, ensuring timely implementation of necessary controls and processes.
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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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Accountable for protocol review policies and procedures including ensuring implementation of FCR, DMR and VVC review in accordance with regulation, making continuous improvements to maximize flexibility in the regulations and reducing administrative burden to the Investigator, the IACUC, and the OAWA. Represent protocol review in accreditation documentation, regulatory reports and during regulatory inspections.
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In the Department of Pathology, the Morgue Attendant works under general supervision of the Technical Operations Manager of Autopsy and Decedent Affairs. All logout entries in the Morgue Logbook are verified using the Undertaker's Removal Slip.
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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is responsible for executing model risk management activities consistent with the framework, industry best-practice and regulatory guidance.
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The Curriculum Manager works under the supervision of the Director of Curriculum within the Office of Educational Affairs (OEA). Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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A minimum of 12 years of experience in construction roles (project engineer, site superintendent, construction project manager) Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Saugus, MA
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