JOB DESCRIPTION

Job Summary:

• Author Global Documents in partnership with functional area SMEs and business co-owners ensuring that global documents are designed to a comprehensive level, and agreed upon by stakeholders.

• Responsible for working with corporate functions, influencing process, tool and template improvement and helping to facilitate alignment across multiple functional manuals.

• Additionally, this role will ensure all documents authored are aligned to compendial, ICH, FDA and other regulatory guidance expectations. The role requires to work independently and manage multiple assignments simultaneously with business co-owners and functional key SMEs.

Essential Job Functions:

• Author and fully manage the lifecycle (development, review, change control, execution, approval, effective status, training activities, revision, obsoletion, periodic review etc.) of global documents. 

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