ImmunityBio
Regulatory Documentation Specialist II
Summit, NJ · Mid
Sponsorship not specifiedDetected 30 days ago
CommunicationOrganizational Skills
About the role
- Working Environment / Physical Environment
Responsibilities
- 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.
- 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.
- Create and maintain electronic project folders for projects
- 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.
- 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
- Prepare document shells for inclusion of text and data
Requirements
- Bachelor's Degree in life sciences or technical discipline with 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required
- High school diploma with 6+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required.
- Working knowledge of Veeva Vault especially Veeva RIM
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Bachelor's Degree in life sciences or technical discipline with 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or
Skills
- Knowledge, Skills, & Abilities
- Strong organizational skills, written and oral communication skills, and attention to detail
Compensation
- The hourly base pay range for this position is below.
Benefits
- Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements
Visa & Work Authorization
- 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
Apply directly at ImmunityBio →Create a free account for alerts like thisView ImmunityBio immigration profile
This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.