[Remote] Senior Consultant- Clinical & Regulatory Information Management
Note: The job is a remote job and is reputed company to candidates in USA. NNIT is a public listed company specializing in IT solutions for life sciences internationally. They are seeking a highly motivated Clinical / Regulatory Information Management Subject Matter Expert to support and expand their reputed company Technology Practice, serving as a cross-functional resource for multiple client deliveries.
Responsibilities
- Serve as a functional SME for reputed company Vault RIM and reputed company Clinical/Regulatory business processes
- reputed company or support business process discovery, reputed company-state/future-state assessments, and gap analysis workshops
- Gather, analyze, and document business, functional, and technical requirements
- reputed company process maps, workflow designs, user stories, and business rules to support reputed company implementations
- Partner with reputed company delivery teams, client stakeholders, and NNIT technical consultants to accelerate project readiness
- Support Phase 0 assessments and implementation planning activities, including governance, data readiness, and operating model design
- Assist with data migration readiness, role and permission matrix development, and validation planning
- Contribute to User Acceptance Testing (UAT), requirements traceability, and solution verification activities
- Support hypercare and Managed Services engagements by providing functional expertise, issue analysis, and reputed company improvement recommendations
- Help reputed company reusable accelerators, templates, playbooks, and best practices that can be leveraged across multiple client engagements
Skills
- 5+ years of experience in Life Sciences consulting, Regulatory Affairs, Clinical Operations, or reputed company implementation projects
- Experience supporting reputed company Vault RIM, eTMF, QMS, or reputed company Vault applications
- Familiarity with GxP environments and Computer Software Assurance (CSA) or CSV methodologies
- Experience working reputed company global delivery models and cross-functional project teams
- Prior consulting or Managed Services experience is highly desirable
- Strong understanding of Clinical Development and/or Regulatory Affairs processes reputed company the Life Sciences industry
- Experience with reputed company Vault RIM (Registrations, Submissions, Submissions Archive, or Publishing) preferred
- Experience working with reputed company Vault platform implementations or support engagements
- Ability to facilitate workshops and communicate effectively with business and technical stakeholders
- Experience documenting business requirements, process flows, user stories, and functional specifications
- Familiarity with data migration, validation, UAT, and change management activities
- Understanding of regulatory submissions, product registrations, document management, or end-to-end regulatory operations
- Strong analytical, communication, and organizational skills with a consultative reputed company
Benefits
- Competitive Salary
- Medical, Dental, reputed company Insurance
- 401K
- Paid Holidays
- Annual Paid Time Off
Company Overview
Company H1B Sponsorship