James Anderson
Senior Manager @ Moderna | Managing Regulatory Information Systems
- Role
- Senior Manager at Moderna
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About James Anderson
With over 3.5 years at Moderna (20 + years in industry) and extensive experience in…
Experience
Senior Manager
Jan 2022 — Present · Philadelphia, PA, US
Reporting to the Director of Regulatory Information Management (RIM) primarily responsible for providing end-user support for regulatory systems and process, enabling submissions such as INDs, CTAs, Amendments, BLAs, Supplements, MAAs, and Variations. Lead and coordinate the following processes:• Manage the development and maintenance of procedure documents, and best practices for RIM technologies.• Manage day-to-day operations and business support for all new and existing RIM technology, including troubleshooting issues, systems and process training, and business administration.• Manage UAT testing executing for systems that support RIM processes.• Lead cross-functional RIM Governance Team, run monthly meetings, record meeting minutes and capture actions to drive system improvements.• Provide subject matter expertise on RIM related projects.• Liaise with system and service vendors
Education
Fairleigh Dickinson University
Computer Science
2017
Duke University
Computer Science
1989 — 1993
Fairleigh Dickinson University
Computer Science
Skills
- Consulting
- Documentum
- Enterprise Content Management
- Project Management Office (Pmo)
- Return on Investment
- Software Development Life Cycle (Sdlc)
- Service-Oriented Architecture (Soa)
- Analytics
- Agile Methodologies
- Data Warehousing
- Java Enterprise Edition
- Enterprise Software
- Enterprise Architecture
- Software Development
- Scrum
- Sharepoint
- Soa
- Requirements Gathering
- Sdlc
- Solution Architecture
- Weblogic
- Pmo
- IT Strategy
- Software Project Management
- Crm
- Business Intelligence
- Digital Preservation
- Integration
- Document Management
- Project Portfolio Management
- Information Architecture
- Business Process Design
- Requirements Analysis
- Content Management
- Strategy
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