The SOP position will be responsible for leading and executing activities related to procedural document development and training within R&D QA & Compliance and R&D as a whole. This includes but is not limited to: quality facilitation of procedural document workgroups, authoring, reviewing, editing and quality control of documents, reviewing regulatory requirements, identification and assignment of training in Shire’s Learning Management System, and training development and implementation.
The person assuming this role will be expected to lead Cross functional teams of Process Owners, Content Experts and functional area Subject Matter Experts, through a R&D document harmonization and biennial review process that is critical to Shire meeting its compliance requirements
The SOP position 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 Shire’s CDMS. In addition he/she will lead the effort of transitioning documents from an existing CDMS that is scheduled for decommissioning in the 1Q15
The Consultant SOP must have at least 10 years of SOP Writing experience, have proven Project Management/Project Facilitation experience as well as exceptional interpersonal skills and attention to detail to lead content experts through the development of multiple Procedural Documents simultaneously.
10 years of SOP Writing experience, have proven Project Management/Project Facilitation experience as well as exceptional interpersonal skills and attention to detail to lead content experts through the development of multiple Procedural Documents simultaneously.
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
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Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.