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Novo Nordisk’s Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions that drive patient access to innovative products.
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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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Knowledge of or an interest in political, economic, and international affairs. Build and enhance content for Dow Jones Risk & Compliance in areas including anti-money laundering, anti-corruption, and economic sanctions.
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Work with CMC cross-functional teams and Regulatory Affairs teams. Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs.
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Keywords-auto cad, 3D, sketchup,indesign, rhino, vray, illustrator, design development, hand sketch, adobe, hospital, schools, institutional, sketch-up, health care, sustainable, retail, banking, mixed-use, registered architect, project architect, CADD, CAD, photoshop, excel, freelance, survey.
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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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Interacts internally with Strategic Pricing & Contracting, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting Strategy colleagues across all franchises, and all others, including global colleagues/counterparts, on a routine basis.
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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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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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Train and obtain access on company tools and systems that support contracting, PO, and invoicing for regulatory affairs in the US and EMEA. Support budget tracking as directed by company DRI Efficiently prioritize and manager multiple tasks, ensuring all tasks are completed within the given deadlines.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.
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We are hiring a Maintenance Manager at our CJ ethnic foods plant in Robbinsville, NJ. This person leads or directs plant maintenance activities for all shifts within their assigned area, including preventative maintenance, floor maintenance diagnosis and repair, emergency maintenance, refrigeration, equipment noise control, electrical, purchasing and inventory, license and standards compliance and safety procedures.
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Typical tasks may include the design, installation, and monitoring of groundwater, surface water, and soil gas systems, collection of surface and subsurface soil samples for environmental and geotechnical analyses, participation in the design and implementation of both in-situ and ex-situ remedial actions; and assisting or leading the preparation of proposals and project documents.
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With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. SpecialtiesProcess Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
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affairs job Title: affairs project manager in Princeton, NJ
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