Veeva RIM Registrations & Submissions Consultant
Client: global pharmaceutical company
Location: 100% remote from the US
Duration: 18-month contract
Overview:
Seeking a Veeva RIM Registrations & Submissions Consultant to support the implementation of Veeva Vault RIM Submissions and Registrations for submission planning activities.
This consultant will act as a primary liaison between planners, IT, and vendor partners to ensure successful planning, configuration, and implementation of Submission Planning capabilities across the Veeva RIM Registrations and Submission modules.
Key Responsibilities:
Business Requirements & Workflow Design
- Collaborate with functional area stakeholders (Regulatory Affairs, CMC, RPP, RRO) to gather, validate, and prioritize business requirements for submission planning processes in Veeva RIM Registrations and Submissions.
- Define user stories, acceptance criteria, and functional specifications for content planning features.
- Translate planning needs into system capabilities, ensuring alignment with Veeva’s standard configurations and Our Company’s operational objectives.
- Design end-to-end workflows for content planning including planning creation, versioning, ownership assignment, review cycles, and status tracking.
System Implementation & Support
- Partner with business users, Veeva consultants and IT to configure planning templates, deliverable hierarchies, and related metadata in Veeva.
- Define and implement document-to-plan mappings, content plan item types, and relationships between Content Plans and Submission Registrations.
- Support sandbox and UAT planning and validation activities focused on planning scenarios, including development of test cases and scripts that reflect realistic planning and cross-functional dependencies.
- Assist in mapping and migrating legacy planning artifacts into Veeva RIM Content Plans, ensuring fidelity of commitments, owners, and timelines.
- Support data integrity checks and reconciliation between plan items, obligations/commitments, and associated documents.
Training & Change Management Support
- Develop role-based training materials and quick reference guides for business users on planning functionality, including creation and maintenance of component plans.
- Assist with conducting workshops and knowledge-transfer sessions to socialize new planning processes and best practices across impacted functions.
- Provide ongoing hyper care support for planning users post-go-live, including troubleshooting planning scenarios and refining configurations based on user feedback.
Cross-Functional Collaboration
- Work closely with the Integration Lead and FA SME to ensure that processes for planning align with upstream and downstream processes.
- Participate in planning workshops and governance forums to align content planning, registration, and publishing hand-offs, ensuring traceability from plan items to submission deliverables.
Qualifications:
- 3-5+ years of experience in Life Sciences or Regulatory Affairs.
- Hands-on experience with Veeva Vault RIM Submissions, with demonstrable experience implementing or configuring Submission Content Planning (Content Plans, plan items, commitments, milestones).
- Familiarity with regulatory submission types (eCTD, IND, NDA, ANDA).
- Strong skills in requirements elicitation, process mapping, user story writing, and acceptance criteria definition.
- Experience with system migration, UAT, validation, and training delivery.
- Strong stakeholder engagement, communication, and workshop facilitation skills.
Preferred Skills:
- Prior involvement in large enterprise regulatory transformation or implementation programs.