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This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.
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Key Responsibilities Accountable for end-to-end program management for biologics marketed product stability program, including: Stability product strategy: determines/communicates stability requirements (e.g. Health Authority annual commitments, product/process change qualification batches, etc.
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The optimal candidate will have experience in retail & business banking software (fintech) product strategy & management, competitive assessment, business case development, organizational management and cloud, micro services and mobile technologies, bringing that rich experience to our client’s digital delivery channels.
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It's a customer focused senior application analyst position with an emphasis on analyzing business requirements, creating functional technical designs, and code development utilizing IDMS, DB, VSAM and COBOL in a batch environment.
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and 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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Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Develop and implement premium skin care products including cleanser, sunscreens, and anti-aging products from idea to scale-up by working together with extended R&D team and Contract Manufacturers, ensuring the development of the product meets all formulation requirements and successful scalability.
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This position works closely with the Division of Enrollment Management, the SEBS Office of Global Engagement, Rutgers Study Abroad, Student to Professional Internship Network (SPIN), and Rutgers Cooperative Extension to guide program development and implementation.
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Own the administration, management, development, and deployment for all Salesforce Marketing Cloud initiatives. We are seeking an experienced Marketing Automation Manager that will be the Technical Owner and Digital Product Manager for our Salesforce Marketing Cloud implementation.
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These activities include new product development projects, business continuity projects, financial terms, supply management, and partnership agreements. Brand Manager will lead the high priority initiative to define and execute the strategy to enhance value and access for the Respiratory portfolio, support the development of a cross-category initiative to define and execute the strategy for Haleon Children's portfolio, and have Management of the overall relationship of the partnerships with Kenvue (Nicorette) and Sanofi (NicoDerm and other brands) and the Commercial contact for the alliance with AstraZeneca (Nexium.
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Delivers functional business management, to include, financial planning/budgets, product management, marketing and sales efforts, and customer service initiatives and data analysis/decision support.
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Lead end-to-end test executions by using SQL programming, database development & management, SOAP UI/Ready API tool, R Studio for webservices/web applications, Selenium web driver, testNG and Maven technologies under JAVA platform, Putty and WinSCP Tools.
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Work with R&D scientists, regulatory, commercial, and management teams to provide quick and accurate IP and other legal advice on all aspects of the Hatch-Waxman Act, including the timing of product approvals and launches.
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Experience with ARM architectures, Raspberry Pi, Nvidia Jetson and other embedded platforms preferred·Knowledge of Visual Studio This is an exciting opportunity for a skilled Senior Software Engineer to contribute to cutting-edge projects in fast growing company supporting consumer and defense drone development.
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product development management drug jobs Title: development director Company: Omeros in South Plainfield, NJ
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