PROCESS AND QD MANAGER
Descripción de la oferta de empleo
• Supports/guides BPOs in the process to develop or update process design (end-to-end Process design including set-up expectations, perform Elaboration Workshop and coordinate Cross-functional Alignments, Document Authoring responsibilities) • Ensures adherence to R&D documentation standards, process orientation, simplification, visualization, harmonized core language, regulatory compliance and harmonization of processes and QDs within GDO • Develops/revises process flow diagrams using the designated system and notation standards and supports the GDO organization as an expert for efficient process design and illustration Controlled Document & Managed Information Document Management.
• Responsible for the development, review/revision, maintenance and continuous improvement of Quality Documents (incl.
CDs and MIs) for GDO • Ensures timely review/revision of existing processes & QDs within GDO, maintaining compliance with review/renewal timelines • Owns GDO Managed Information Document ManGo Cabinet • Coordinates review and revision of documents with all appropriate stakeholders in cooperation with the process/document owner • Ensures compliance with document content and formatting standards • Represents GDO in clients R&D Development Excellence Council (DEC) and manages related activities • Ensures timely and adequate communication on behalf of the DEC to the GDO organization • Experience in clinical research in a CRO, pharma or biotech company • Knowledge of ICH Good Clinical Practice (GCP) guidelines • Knowledge of Good Documentation Practices • Solid organizational skills, including multitasking and time-management • Good interpersonal skills • Demonstrated good written and verbal communication skills • Fluency in English (oral and written) • Experienced user of MS Office 365 toolset (Word, Excel, SharePoint, PowerPoint etc)
Detalles de la oferta
- ICON
- En toda España
- Sin especificar - Sin especificar
- 17/05/2024
- 15/08/2024
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