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Partner closely with colleagues in the Marketing, Business Development, R&D/Process Technologies Clinical Operations, Strategy, Regulatory Affairs, Market Access, and other key functions, to build integrated evidence generation across HEOR, RWE, Pre- and Post-market studies to support product launch and life cycle management.
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Functional knowledge of Pricing & Reimbursement, Outcomes Research, Government Affairs, Corporate & Business Communications, Regulatory Affairs, Payer Management. Understanding of regulatory policies and impact of public relations within US.
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The Vice President, Medical Affairs Portfolio Evidence Strategy, will lead a dedicated team to execute Genmab's comprehensive medical evidence generation strategy across all assets and therapeutic areas as well as ensure successful operational execution.
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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Publish, review, submission and archival of assigned global eCTDs and paper submissions using Regulatory Affairs systems/tool. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Senior Director, Global Regulatory Affairs Strategy. Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned.
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Ability to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messaging. Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books.
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This role will oversee the Hemoglobinopathies marketing organization and will work closely with Global Marketing, Medical Affairs, Market Access, Commercial Excellence and Strategic Partnerships and Engagement to deliver on the Hemoglobinopathies ambition.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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BA/BS degree or equivalent, at least 6 years pharmaceutical industry experience, and prior Regulatory Operations experience required. Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
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Identify develop operational institutional pathways to grow scientific engagements research and data for the enterprise with a special focus on community oncology centers and accounts for ongoing working groups and consortium support Contributes to the scientific affairs HCE partnership execution with select external research partners to maximize effective and compliant delivery of research with external organizations.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Stays up to date and compliant with the regulatory landscape related to drug safety and data analyses. Minimum of - years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry.
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affairs job Title: regulatory affairs Company: Thermo Fisher Scientific in Lawrence, NJ
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