Remote Solution Architect Regulatory Information Management (RIM)/(AV)

VISION INFOTECH INC.; United States; Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

E-Verified Company

Job summary

VISION INFOTECH INC. seeks a Solution Architect for Regulatory Information Management (RIM) to lead end-to-end architecture, governance, integration strategy, and data migration for the Ennov RIM platform in a remote setting.

You will collaborate with Regulatory Affairs, Quality, Enterprise Architecture, Data, Integration, and Security teams to ensure alignment with enterprise standards. The role requires deep RIM expertise, regulatory submissions knowledge, and a track record in life sciences

Qualifications

• Enterprise application architecture experience.
• Solution Architect for enterprise software implementations.
• Prior experience implementing Regulatory Information Management (RIM).
• Experience with Regulatory Affairs applications and Quality Management Systems.
• Experience with Clinical or Life Sciences platforms.
• Knowledge of Regulatory Domain processes, submission management, and regulatory archives.

Responsibilities

• Deliver end-to-end architecture and design governance for the RIM implementation.
• Configure master data and submission templates to support regulatory submissions.
• Design submission workflow templates for efficient review and approval routing.
• Create templates for regulatory correspondence, archiving, publishing, and archiving.
• Deliver dashboards and reports for master data and submissions processes.
• Provide integration for master data updates and submissions development.
• Oversee data migration of in-scope submissions and attach to master data.

Skills

Enterprise architecture

Solution architecture

Regulatory Information Management

Regulatory affairs applications

Quality Management Systems

Regulatory domain experience

Clinical or Life Sciences platforms

Job description

Solution Architect -- Regulatory Information Management (RIM)

Location: Remote

Experience: 15 years

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

Regards,

Avinash Kumar

Senior Recruiter
VISION INFOTECH INC
Phone:
Email: 368 Main Street, st #3, Melrose MA 02176

E-Verified Company