Solution Architect – Regulatory Information Management

Job Description:
This company is implementing Ennov Regulatory Information Management (RIM) as the strategic platform to support regulatory submissions, regulatory correspondence, submission lifecycle management, reporting, workflow automation, integrations, and archival capabilities. Ennov has been selected as the preferred RIM solution following a vendor evaluation process.

The Solution Architect will be responsible for the end-to-end architecture, design governance, integration strategy, data migration approach, and technical leadership for the implementation of the Ennov RIM platform. The role will work closely with Regulatory Affairs, Quality, Enterprise Architecture, Data, Integration, Security, and Vendor teams to ensure successful deployment and alignment with enterprise standards.

The RIM platform is expected to enable regulatory registrations, submissions, publishing, archival, workflow automation, and integration of regulatory data across the enterprise.

Key Responsibilities

• Solution Architecture & Design
• Configure master data to support regulatory submission identification, templates and analysis
• Configure submission templates (to accelerate construction of submissions)
• Configure submission workflow templates (to assure routing for review and approval in the most efficient manner)
• Configure supporting templates and workflows, such as Regulatory Correspondence
• Configure submission archiving
• Deliver reporting and dashboards for both master data and the submissions process (dashboards)
• Deliver integration to support Master Data updates
• Deliver integration to support submissions development (e.g. data files, studies reports)
• Perform data migration of in-scope completed submissions, attaching migrated submissions to appropriate master data and disposition

Experience

• 10 years of enterprise application architecture experience.
• 5 years as Solution Architect for enterprise software implementations.
• Prior experience implementing:
  • Regulatory Information Management (RIM)
  • Regulatory Affairs applications
  • Quality Management Systems
  • Clinical or Life Sciences platforms
• Regulatory Domain Experience
• Strong understanding of:
  • Regulatory Affairs processes
  • Submission management
  • Product registrations
  • Regulatory correspondence
  • Submission publishing
  • Regulatory archives