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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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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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Working with the Sr. Director of Marketing, Director of US Product / Brand Marketing, the Associate Director proactively engages and collaborates with a cross-functional team, which includes but is not limited to: Sales, Market Access, Medical Affairs, Finance, Regulatory Affairs, Legal, Health Economics, Policy, I&T, Comms and Training in the development of brand positioning and messaging, and the execution of the strategic plan in the US market.
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The Translation Management Services group rests at the heart of ADP’s global initiatives, operating as a centralized center of excellence for development and delivery of multilingual content.
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Proven track record of success in marketing management roles, with a minimum of 5 years of experience in product marketing, go-to-market, or related fields. The Product Marketing Manager will be responsible for overseeing all aspects of marketing strategy, planning, and implementation, with a focus on product commercialization and market penetration.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Ability to coordinate global activities, facilitate issue resolution and conflict management.
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Minimum of 5 years of purchasing experience in a Manufacturing or Product Development setting utilizing MRP, supply chain management software and tools, Great Plains preferred. The NPI Sourcing Specialist is a key member of both the Product Development team as well as the Procurement/Purchasing team.
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As part of the Market Risk Strategy team within the Global Risk Management organization, the Senior Market Risk Analyst will be responsible for development and advancement of replicating portfolios (RP) supporting MetLife s asset liability management (ALM) and Investment performance attribution processes.
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SAS, ADaM, SDTM, CDISC, qc testing, Clinical research, biostatistics, vendor management. Actalent is an operating company of Allegis Group, the global leader in talent solutions. Program SDTM and ADaM datasets according to the dataset specifications.
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We are seeking an experienced Field Service Technician (FST), Mechanical, for the Folding Carton, Hot Foil Stamping product line. The FST provides timely and efficient machine repairs and installations primarily for customers in the Folding Carton product line.
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Resource will be supporting continued build out of Treasury, investments, cash management and payments capabilities at First Citizens Bank. Experience working with data management projects having experience in data analysis, data governance, data quality and lineage.
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The manager shall enlist the help of other disciplines and departments when necessary, such as program management, production, supply chain, quality, and finance. The Systems Engineering Manager is responsible for the systems engineering team which creates system products such as systems engineering management plan, requirement management including traceability, system analysis and simulation models, and documents.
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The Senior Technical Manager collaborates closely with Director level leadership and maintains a strong network of technical contacts at our customers, government agencies, research labs, universities, and Honeywell global engineering centers.
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Experience in presenting and explaining product management, agile methodologies, and coaching techniques to stakeholders (if you can explain the purpose of story points, t-shirt sizing, why this team is scrum vs.
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global marketing product management jobs Title: program manager marketing in East Hanover, NJ
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