Regulatory Documentation Specialist II
About The Position
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. 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.
Requirements
- 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.
- 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
Responsibilities
- Create and maintain electronic project folders for projects
- Assist in ensuring Veeva RIM is up to date by uploading all submission, Health Authority correspondence, etc.
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
