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. Job Summary The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling
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will provide process validation leadership for one or more vaccine or biologics drug substance manufacturing processes. The position leads and/or participates in the planning, preparation, execution, and
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. Proven experience with PLC Allen Bradley/Rockwell/Siemens. Able to define multi-year strategic Automation direction. Collaborate and align with above site/Global teams. PSM Process Safety Management
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. Proven experience with PLC Allen Bradley/Rockwell/Siemens. Able to define multi-year strategic Automation direction. Collaborate and align with above site/Global teams. PSM Process Safety Management
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sub team(s) to ensure collaboration and seamless connectivity. ROLE RESPONSIBILITIES Responsibility to assist/lead development and execution of simple to moderately complex clinical studies; on more
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wide range (non-routine) complex audits (minimal to no oversight - as needed). Execute audit strategy and lead process audits. Act as a reviewer of audit reports from outsourced or routine audits. Assess
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the acquisition and divestiture of TMF contentwhile developing repeatable efficient process for TMF in integrations Lead design and execution of remediation projects and improvement projects Configure Study
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Clinical Research and may take the lead on company-wide, global process improvement initiatives, and champion's process enhancements and solutions for complex issues. Leads change for Vaccine Clinical
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affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and
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regulations Independently conducts wide range of routine/(non-routine) complex investigator site audits (minimal to no oversight - as needed) Executes audit strategy, leads/supports process audits, and may