Regulatory Documentation Specialist II

ImmunityBio Job Opportunity

Company Overview ImmunityBio, Inc. 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.

Position Summary

The Specialist II, Regulatory Documentation reports to the Director, Regulatory Documentation and will provide support in the management and publishing of documents ensuring its conformance with Health Authority requirements. This position will assist staff in the document management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules.

Essential Functions

• Create and maintain electronic project folders for projects
• Generate electronic files for working documents
• Format documents prepared or received according to stipulated style guides for reports, assessments, regulatory submissions, letters, etc.
• Format and compile documents according to requirements specified by Regulatory Agencies
• Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone
• Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
• Prepare document shells for inclusion of text and data
• 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
• 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 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
• High school diploma with 6+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required.

Knowledge, Skills, & Abilities

• Working knowledge of Health Authority procedures and guidance regarding document management and electronic submissions
• Working knowledge of Electronic Document Management Systems
• Working knowledge of 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 (Monday through Friday) 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 the close study of scientific and regulatory documents.
• They 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.

$45.66 (entry-level qualifications) to $50.23 (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.

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.