Consultant SOP Writer will be responsible for executing activities related to procedural document development as well as training development and deployment within R&D GDS and QA & Compliance.
This includes but is not limited to:
- Review of regulatory requirements, quality facilitation of procedural document workgroups, authoring, reviewing, editing and quality control of documents, identification and assignment of training in the Learning Management system, and training development and implementation.
- The SOP writer is also required to be an expert user of the Controlled Document Management System (CDMS) and will lead work flow facilitation of all Procedural Documents within MasterControl, Shire’s CDMS.
- The Consultant SOP Writer must have strong time management and project management skills as well as excellent interpersonal skills and attention to detail to lead content experts through the development of multiple Procedural Documents simultaneously.