Business Analyst

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Job Description:

We are seeking a skilled and proactive Business Analyst to support the implementation of Veeva Vault RIM Submissions, with a specific focus on authoring capabilities for Life Sciences regulatory submission content management.
This role will serve as a critical liaison between functional area business users, IT, and vendor partners to ensure successful planning, configuration, and implementation of authoring capabilities within the Veeva RIM Submissions module.

Responsibilities: Business Requirements & Workflow Design:

Collaborate with functional area stakeholders to gather and confirm business requirements for the submission content source system, which is based in Veeva RIM Submissions.
Define user stories and business processes, acceptance criteria, and functional specifications for submission-related authoring processes.
Translate regulatory business needs into system capabilities, ensuring alignment with Veeva's standard configurations and Our Company's operational goals.
Partner with functional area business users, Veeva consultants and IT to define, test and implement workflows, document lifecycles, and document metadata.
Support sandbox, conference room pilot planning and execution, UAT planning and execution, and validation activities, including script development.
Assist in mapping and migrating legacy content into Veeva RIM, including testing, to ensure data integrity and compliance.
Support the development of training materials for business users on Veeva RIM authoring functionality.
Provide ongoing support and troubleshooting during hyper care.
Work closely with Integration Lead to implement connectors to other Veeva Vaults, such as Clinical, Quality and Safety.
Participate in workshops and forums to align authoring capabilities with Veeva RIM submissions registrations and planning capabilities, and hand-off to publishing.

Requirements:

3 5+ years of Business Analysis experience in Life Sciences or Regulatory Affairs.
Hands-on experience with Veeva Vault RIM Submissions, especially document management capabilities, including E2E process with Submission Planning utilizing Veeva's Content Plans (e.g., GCP, SCP, RLCP).
Familiarity with regulatory submission types (eCTD, IND, NDA, ANDA) and Health Authority requirements.
Strong documentation, stakeholder engagement, and communication skills.
Experience with user requirements and business process development, system migration, validation, and training delivery.
Knowledge of controlled vocabularies, regulatory objectives, and commitment tracking within Veeva RIM is a plus.

Preferred Skills:

Understanding of integration points between Veeva RIM and other Vaults (Clinical, Safety, Quality).
Prior involvement in large enterprise transformation programs.

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