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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management.
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Review incoming correspondence from the USPTO and all foreign patent offices and agents, and timely docket all due dates worldwide. Correspond with internal/outside patent counsel and foreign agents during prosecution of applications and assist with preparation of prosecution papers such as responses to office actions and information disclosure statements.
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Collaborates closely with the US HEOR group on biologics-related activities (providing input into early economic models/endpoints, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications), and presenting this back to the medical affairs teams.
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Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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The position requires close collaboration with home office marketing, regional sales, medical affairs, and advocacy and strict adherence to the HCC, legal, and regulatory guidelines for promotional activities.
$99,000 - $170,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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We seek attorneys to assist with document review, privilege review, expert testimony, legal research, and foreign language translation. Examples: Relativity, Concordance, ViewPoint, etc. Korean Document Reviewer.
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Collaborate with the International Tax Director on Subpart F, GILTI, FDII, Sec. 163(j), BEAT, foreign tax credit, and other international items included on the US Consolidated Tax Return. Build and maintain effective relationships with Tax Planning, Tax Reporting, Tax Technology, Transfer Pricing, Tax Disputes, and the Controller’s Group.
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Provide Medical Affairs support and input into launch readiness activities including labeling, life cycle management, and other early commercialization initiatives for late-stage Oncology pipeline products.
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Background in community engagement, advocacy, public policy/affairs, and/or health and social equity. Master’s degree in public health, nutrition, exercise science, public policy, or public administration preferred.
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5-7 years of pharmaceutical and or life sciences marketing experience; additional pharmaceutical experience in sales, medical affairs, and market access a plus Experience with marketing and/or selling biologics within at least two of the following disease areas is REQUIRED : dermatology, immunology, rheumatology.
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S/he will report to the Executive Director and is a key business partner for Immunology & Neuroscience Medical Affairs. The Senior Director, Medical Performance and Outcomes (MPO) will support the MPO capability globally to drive the value of Immunology & Neuroscience Medical Affairs.
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ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey. Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.
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foreign affairs jobs Title: data Company: Abbott Laboratories in Pennington, NJ
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