Veeva RIM Specialist

Veeva RIM Specialist

ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

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 4+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
• High School diploma with 8+ years of regulatory operations experience in the biotechnology or pharmaceutical industry 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 uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

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.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.