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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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As a certified PMP with a breadth of hands-on project management experience in the Pharma/Biotech/Cell Therapy regulated environments, the CTDO Sr. PM is expected to perform with minimal supervision and effectively facilitate the successful delivery of a wide process development and commercialization activities within the CTDO organization from initiation to completion while remaining aligned with company strategy, commitments and goals.
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6+ years relevant experience in communication strategy development, product/project management, operational effectiveness. The Agile Product Owner Senior Advisor leads large, multifunctional initiatives to enhance products and capabilities impacting Evernorth Pharmacy.
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This OpportunityWSP is initiating a search for a Full-Time Safety Manager to join our management team helping oversee the MBTA Commuter Rail Safety Resiliency Project. Coordinates with the Construction Manager and Resident Engineer to review safety risks inherent in upcoming field operations in each project area.
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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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The mission of the Verizon Communications Manager is to drive excellence in managing crises as well as reputation management, brand protection and enhancement. This Communications Manager must act like a journalist in their own right.
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On-Board Scientific is hiring a Validation – Project Manager (Bilingual Japanese/English preferred) based out of Summit, NJ! Ability to identify risks and proactively develop mitigation plans Comfortable working in a multi-cultural environment Project Management experience (min years) (PMP certificate or proven experience) Fluent management for PM tools such as Smartsheet, Microsoft Time Pro, Microsoft Project Plan or others.
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Net, Python Good to have: Platforms - Chaos Engineering, HashiCorp Vault(Secrets Manager), Load balancer & cert automation and Delphix Agile methodology and Scrum management, Jira Job Description: Design and embed technical processes to ensure Audit remediation points/RCA (risk and control assessment) actions are actioned and controlled in a timely manner.
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In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.
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Define resourcing and budget needs to deliver the aligned E2E Master Data Plan. Partner with global Data Management Transformation & Governance teams to bring required capabilities and resources to deliver the E2E Master Data Plan for the Project (e.g. Certified Master Data Lake, SAP PLM, SAP MDG, Data Quality capabilities, etc.
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Where you’ll be working In this hybrid role, you'll have a defined work location that includes work from home and a minimum eight assigned office days per month that will be set by your manager.
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Product Leadership: Lead cross-functional teams in the design, development, and launch of Kubernetes services, with a focus on usability, performance, and integration capabilities.
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The Sr Environmental Scientist is responsible for planning and implementing field activities, evaluating laboratory data and measurements collected during field work and preparing technical documents under the direction of a Project Manager.
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Utilizes diary management system to ensure that all claims are handled timely. Applies litigation management through the selection of counsel, evaluation and direction of claim and litigation strategy.
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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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project management product manager development agile jobs Title: system integration in Morristown, NJ
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