What are the responsibilities and job description for the Business Analyst position at Katalyst CRO?
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.
- 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.
- 35 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.
- Understanding of integration points between Veeva RIM and other Vaults (Clinical, Safety, Quality).
- Prior involvement in large enterprise transformation programs.