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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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Responsible for the global regulatory evaluation of CMC change controls with supervision. Participate in global regulatory interactions with health authorities, with supervision. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Maintenance Manager will establish and maintain the department's CMMS (computerized maintenance management system) and pursue training to become the Radiation Safety Officer for the facility.
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Our spectrum of Global Information Reporting services range from FATCA, CRS, chapter 3 and 61 tax compliance globally, tax form validation services, Qualified Intermediary and Withholding Partnerships regimes, technology development in these areas, consulting services, controversy, risk management and audit readiness for these regimes.
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The entities of Citrin Cooperman & Company, LLP and Citrin Cooperman Advisors LLC are independent member firms of the Moore North America, Inc. (MNA) Association, which is itself a regional member of Moore Global Network Limited (MGNL.
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Our BusinessWe are a global leader in environmental consulting - made stronger with the recent acquisition of Wood’s Environment & Infrastructure business and Golder - with world-class expertise in environmental, social and governance (ESG), climate resiliency & sustainability (CRS), and earth sciences.
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You may possess a vast background (additional certificates help support your deep security knowledge (CISSP, GSEC, CISA, CISM, CRISC, MCSD), comprising of functional experience working in a global hybrid cloud environment, including AWS, Azure, O365, and GCP. Experience with Data Governance or Data Compliance Standards is valuable.
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The work hours for this Midnight Shift position are Sunday Night - Thursday Night 10:30p - 7:00a. Must be able to work flexible hours including night and weekends with little advanced notice.
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Partners with internal colleagues (Brand Teams, Hub management, Global/Regional TA Leads, Area/Regional medical) to ensure creation of relevant core content to meet customer needs. + Identify global medical information insights based on Medical Information inquiries and partner with cross-functional colleagues to identify scientific gaps and strategic solutions.
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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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Innova Solutions is immediately hiring a Trial Supplies ManagerJob Title: Trial Supplies ManagerPosition type: Full-time ContractDuration: 06 MonthsLocation: Remote, USAPay range: $74 -$ 78 Per HourAs a Trial Supplies Manager, you will:This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.
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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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Administers medications to patients and monitors them for side effects and reactions.
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Participate in global sales forecasting alongside Sales, Operations, and Finance as part of the S&OP and demand planning processes. The Senior Brand Manager oversees the pivotal, cross-functional collaboration of Marketing, Product, and Sales teams to ensure successful brand and go-to-market strategies that build brand awareness, drive engagement, and ultimately increase global market share.
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This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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global night jobs in Morristown, NJ
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