Veeva RIM Specialist

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Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Veeva RIM Specialist will provide expertise and guidance in the management and publishing of regulatory documents ensuring their conformance with Health Authority requirements. This role is hands on and execution focused, working closely with all of regulatory affairs to support all US and ex-US regulatory activities and maintain inspection-ready system. This position will assist staff in submission and document management activities using Veeva RIM software. Essential Functions Create and maintain electronic project folders for projects. Execute the upload, tracking, life cycle maintenance of regulatory submissions, including INDs, BLAs, CTAs, for US and ex-US regions within Veeva RIM. Maintain Veeva RIM by uploading all submissions, Health Authority correspondence, etc. Track all regulatory meetings, questions, information requests, and responses ensuring proper linking within Veeva RIM. Upload and manage Word and source documents in Veeva Vault to support collaboration, version control, and document updates. Ensure regulatory documents received via email, secure links, or external portals in addition to gateway submissions are captured and filed appropriately. Assist in responding to internal audits, health authority inspections, and regulatory inquiries related to RIM documentation. Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements. Configure Vault objects, lifecycles, workflows, document types, and metadata to support business processes. Provide technical and functional support for users including, but not limited to, access to Veeva RIM Assist in system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards. Partner with regulatory affairs, IT, and clinical teams to translate business requirements into technical solutions. Assist in training Regulatory Documentation Specialists, ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed. Act as a key operational contact for Regulatory Affairs regarding Veeva RIM. Provide day-to-day support to system users. Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed. Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience Bachelor's Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or High School diploma with 9+ years' experience required. Hands on experience with Veeva RIM and Veeva Vault required. Familiarity with global regulatory submissions and health authority correspondence strongly preferred. Knowledge, Skills, & Abilities Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission. Expert knowledge of Electronic Document Management Systems. Strong knowledge in Veeva Vault especially Veeva RIM. Ability to work with firm deadlines and adapt quickly to changing requirements and priorities. Strong organizational skills, written and oral communication skills, and attention to detail. Working Environment / Physical Environment This position works on site in Summit, NJ. Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. This po