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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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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice-President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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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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This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.
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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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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.
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The Director, AML Modeling will oversee a team of quantitative professionals by providing strategic and thought leadership to protect the bank from regulatory and reputational risk. Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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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. Any belongings in the Morgue that do not belong to a decedent present in the Morgue must be placed in the Autopsy Suite for review by the Morgue Attendant and supervisor or director.
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regulatory affairs jobs Title: director clinical assoc in Boston, MA
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