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Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The Deputy General Counsel, Codman Specialty Surgical will report to the General Counsel, U.S. and will have primary responsibility for handling or managing a variety of general corporate and commercial contracting matters and will provide advisory services to CSS leaders, including the division president as well as sales, marketing, regulatory, quality, clinical and product development leaders.
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The Messaging Capability Owner (Product Owner) will develop/configure and deploy emails utilizing HeyMarket, Salesforce, and Twilio-SendGrid platforms; with familiarity using Postman API platform and Litmus email testing to help Maximus navigate the complex world of modern solutions.
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A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
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Seamless cooperation and collaboration with the Global Patent Attorney and global product development team for each product, ensuring that each product developed for the US market has a robust US IP litigation strategy at, or shortly after, the product is put on stability trials, and that the regulatory submission is optimized for US litigation.
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Responsible for developing SOPs, in close collaboration with relevant areas, for NA IT to achieve strong governance in System Development and Operation, Asset Management, Strategy Development and Service and Asset Procurement.
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Experience deploying SAP S/4HANA across a broad scope of Finance, including Asset Accounting, Accounts Receivable, Accounts Payable, Banking and Cash Management, Cost and Profit Center Accounting, Profitability Analysis, Intercompany Accounting, Product Costing, Global Sales and Use Tax, Intercompany Accounting, Consolidations and Group Reporting.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The qualified candidate will also work closely with the Personal Care product development team to evaluate new raw materials and establish a mechanistic understanding of these ingredients in skin care applications.
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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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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. You will represent Toxicology & Kinetics in international cross-functional teams and contribute to the dsm-firmenich innovation strategy by supporting Research & Development projects during the entire project life cycle.
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Develop SOPs, in close collaboration with relevant areas, for NA IT to achieve strong governance in System Development and Operation, Asset Management, Strategy Development and Service and Asset Procurement.
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Act as the accountable point of contact from the process development for product/process support for technology transfers and ongoing cGMP drug product manufacturing; Catalent Pharma Solutions in Princeton, NJ is hiring a Senior Scientist, Cell Therapy Process Development who is responsible for contributing to the development of early and late stage clinical cell therapy manufacturing processes.
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Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, legal and NNI Patient Support Solutions. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.
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Profound industry knowledge and an understanding of design and engineering, project economics, interfaces, risks and commercial aspects of offshore wind farm development. Substantial experience in offshore wind project development, execution and / or operation within a project developer organisation or in an Owner's Engineer role within the relevant field.
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Timely completion of Patient Safety Assessment activities through product development, product maintenance and lifecycle management. Responsible for the creation of KPIs for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters.
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product development jobs Company: Deloitte in Princeton, NJ
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