Job Purpose and Key Responsibilities – OSS:
This position is directly responsible for managing and coordinating all R&D Control Documents (policies, procedures and guidance) in accordance with the R&D SOP on Control Documents and in support of the OPtimuM Governance Process. The incumbent will also support control document authors by providing template training and word processing expertise.
• Review documents for compliance with current OPtimuM Tools (template, decision tree, etc). Identify inconsistencies and facilitate changes through the author.
• Create CDMS Workflows to progress new/revised/retired documents through their lifecycle. Complete CDMS metadata entries in accordance with Business Rules to facilitate user searches. Ensure that changes in document status are immediately communicated to stakeholders (such asusers or training database administrators).
• Provide CDMS Reports, based on searches, to facilitate System Governance, and Regulatory Inspections.
• Support fellow Support Specialists, especially during absences and in times of increased workload.
• Contribute to initiatives to improve OPtimuM tools (CDMS, templates & guides, etc.) and communication mechanisms, such as the OPtimuM Intranet Community.
• In partnership with the contract manager, ensure documentation of distribution and recall of control documents to Third Party Contractors, to demonstrate upon audit that R&D contractors are working with authentic versions.
• Support R&D GxP process continuity by providing upon request, control documents in the event of an interruption of service.
• Support CDMS as a Lead User. Solicit and collate CDMS user feedback from R&D users to Principal OPtimuM Support Specialist for relay to CDMS Central Service. Provide input to Central Service for application improvements such as CDMS upgrades or system changes.
• Provide account administration assistance, such as granting access to CDMS,.
• Assists with periodic Quality Review of CDMS folder structure and documents in CDMS.
• Train and mentor fellow Support Specialists to ensure consistent practices.
• Actively participate in initiatives to improve OPtimuM tools (CDMS processes, templates & guides, template training, etc.)
• Maintain OPtimuM communication mechanisms, such as the OPtimuM Intranet Community.
• Independently author OPtimuM communications.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.