Senior Consultant- Clinical & Regulatory Information Management

US
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Details

Type of contract:Full Time

Location(s): US

Language(s):English

Mobility:n/a

Application Deadline:

NNIT is seeking a highly motivated Clinical / Regulatory Information Management (RIM) Subject Matter Expert (SME) to support and expand our growing Veeva Technology Practice. This role will serve as a cross-functional business and technology resource, supporting multiple client delivery of PODs across Veeva RIM and adjacent Clinical and Regulatory initiatives.
The ideal candidate combines a strong understanding of Life Sciences business processes with hands-on experience in Veeva Vault applications, requirements gathering, process optimization, and implementation readiness activities. This individual will help bridge the gap between business stakeholders and technical delivery teams while supporting both implementation and Managed Services engagements.

Duties and Responsibilities:
Serve as a functional SME for Veeva Vault RIM and related Clinical/Regulatory business processes.
Lead or support business process discovery, current-state/future-state assessments, and gap analysis workshops.
Gather, analyze, and document business, functional, and technical requirements.
Develop process maps, workflow designs, user stories, and business rules to support Veeva implementations.
Partner with Veeva 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 continuous improvement recommendations.
Help develop reusable accelerators, templates, playbooks, and best practices that can be leveraged across multiple client engagements.

Strategic Value:
This role is foundational to NNIT's strategy of providing end-to-end support across the Veeva lifecycle:
Strategy 12 Phase 0 Readiness 12 Implementation 12 Hypercare 12 Managed Services 12 Continuous Improvement.
The successful candidate will play a key role in helping clients align business processes with Veeva best practices while enabling faster implementations, sustainable operations, and long-term customer success.

Role Within the NNIT Operating Model:
This position is designed as a flexible, cross-functional SME resource that can:
Support multiple implementation POD's simultaneously
Lead Phase 0 business and process readiness activities
Partner with Veeva and client delivery teams to accelerate implementations.
Transition into post-go-live Managed Services support and optimization activities.
Help build repeatable frameworks and scalable service offerings across the NNIT Quality & Regulatory Technology Practice.

Qualifications and Education Requirements:
5+ years of experience in Life Sciences consulting, Regulatory Affairs, Clinical Operations, or Veeva implementation projects.
Experience supporting Veeva Vault RIM, eTMF, QMS, or related Vault applications.
Familiarity with GxP environments and Computer Software Assurance (CSA) or CSV methodologies.
Experience working within global delivery models and cross-functional project teams.
Prior consulting or Managed Services experience is highly desirable.

Preferred Skills:
Strong understanding of Clinical Development and/or Regulatory Affairs processes within the Life Sciences industry.
Experience with Veeva Vault RIM (Registrations, Submissions, Submissions Archive, or Publishing) preferred.
Experience working with Veeva 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 mindset.

Benefits:NNIT Offers a comprehensive benefits package including:
Competitive Salary
Medical, Dental, Vision Insurance
401K
Paid Holidays
Annual Paid Time Off
Salary:
Dependent upon Experience

Additional Notes:
You will be part of a dedicated, international, and professional team in NNIT's research and development department working closely with the Associate Vice President of the department. As a member of our team, you can count on challenges and development in an attractive and professional setting.

Candidates must be legally authorized to work in the U.S. without requiring current or future visa sponsorship.