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Johnson & Johnson is recruiting for a Senior Director, CMC Regulatory Affairs Biologics – New Modalities, located in either Horsham, PA; Titusville, NJ; Raritan, NJ; or Beerse, Belgium. Reporting to the VP CMC Regulatory Affairs (RA) Biologics, the Senior Director, CMC RA Biologics.
$187,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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The Senior Medical Writer is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.
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External Affairs – Market Access, Public Affairs, Communications. The incumbent interfaces with Clinical, Medical Affairs and business partners including Marketing, External Affairs and Market Access.
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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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Collaborate effectively with various project team members such as preclinical/clinical affairs, quality engineering, operations, regulatory affairs, marketing, etc. Evaluate in vitro and in vivo degradation tensile performance for absorbable polymer based materials and correlate to parameters such as molecular weight and morphology.
$88,000 - $141,450 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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Candidate must be a U.S. Citizen or national, permanent resident, refugee or asylee, or temporary resident under the legalization program of the 1986 Immigration Act. Sunny Delight Beverages Company does not offer practical training positions nor sponsor foreign citizens to obtain work visa or permanent residency (except for certain highly specialized roles such as some R&D positions requiring Doctorate degrees.
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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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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
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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.
$140,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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foreign affairs jobs Title: data Company: Abbott Laboratories in Montgomery, NJ
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