Job Description

Job Title : Senior Specialist, RIM Systems Location: Hyderabad (Hybrid) Position Responsibilities Develop and manage business requirements, standardization of requirements for testing, UAT script design input, lead UAT dry runs, approve test plans and summaries, execution of production releases. Maintenance of existing training artifacts and development of new training deliverables Account provisioning verification and approvals, user access review follow up, user support for training and account request process Provide general system subject matter expertise in process development workshops and enhancement design Develop and maintain business process knowledge, assess user feedback from surveys, review user enhancement requests Design and maintenance of user reports including custom requests Manage third party organization access to systems Assist in system reviews related to Data Integrity, GXP, CAPAs, etc., Create system to user business communications Key Competency Requirements Possess specific regulatory business knowledge, such as general document management principles specifically as applied to regulatory document authoring, review, and approval Experience with Veeva Vault and/or Documentum is desired but not necessary Demonstrates strategic thinking skills, and can drive projects based on group objectives Understanding of Regulatory Operations inclusive of Regulatory Information Management Knowledge / experience with computer systems in an R&D environment Understanding of system validation / testing, and electronic records regulations Experience in leading small projects, as well as collaborating with external customers and contractors Solid understanding of desktop application software suites, especially Excel Good command of the English language, and able to communicate in both written and oral forms. Experience Requirements Minimum of a BS/BA in a relevant scientific or technical field. 1-2 years of pharmaceutical experience.

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