Position SummaryThe 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 position may need to sit for long periods of time and use various computer programs.
- This desk-based role involves close study of scientific and regulatory documents.
- This position will work closely with colleagues throughout the day, often on a project-team basis.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
$50.48 (entry-level qualifications) to $55.53 (highly experienced) per hour
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
