Job Description
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
Required Qualifications
Enterprise application architecture experience.
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
Compliance and audit requirements