Job Description :
Job Responsibilities
IDMP-related business process and data flow mapping
Business process design based on IDMP EU implementation guidance
Assist with the capture and development of business requirements related to IDMP EU implementation guidance
Current/future state gap analysis for all IDMP impacted business areas (i.e. Content mgmt., submissions, PSPM, DCCM, etc
work with impacted business areas on their impacted business functions (i.e. Content mgmt., submissions, PSPM, DCCM)
Identify and capture use cases that test and prove out the IDMP reporting process; identify triggers, roles, systems, etc
Identify training needs and work with internal training partners to create training materials
To support auditability - SOP of who has access to the IDMP tool, processes & procedures around how tool is used in the compliant environment (training that must be completed to get access to tool, roles & responsibilities of people who have access) - create IDMP system owner documentation (i.e. levels of support available, process for reviewing and approving data within the tool, a user guide, an admin guide)
Job Requirement
At least 10 years working in regulatory operations and information management systems and processes (authoring, content management, submission publishing, HRM, eCTD)
IDMP knowledge and experience
Business analysis
Quality Management Systems
Project experience (as a leader or participant)
Skills
Strong Visio and MS Office skills
Communication skills, verbal and written