Regulatory Documentation Specialist III

Benefits

Additional Information

Company Overview 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. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Specialist III, Regulatory Documentation will report to the Director, Regulatory Documentation and will provide expertise and guidance in the management and publishing of documents ensuring their 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 Serve as an advisor to internal departments in the preparation and submission of regulatory documentation 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 QC documents (formatting, bookmarking, hyperlinking, document properties) that were prepared by others Create new submissions in submission software following all SOPs and ensuring all checklists are completed Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone Submit documents to Health Authorities. Ensure that all working files, forms, signout sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements Prepare templates and 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 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 of regulatory operations experience in the biotechnology or pharmaceutical industry required 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 (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. $50.48 (entry-level qualifications) to $55.53 (highly experienced) per h