ImmunityBio
Principal Specialist, Health Authorities
Summit, NJ · Principal
Sponsorship not specifiedDetected 3 days ago
StatisticsClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationOrganizational Skills
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odds of building a lasting career here
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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Assemble the reporting of clinical studies sponsored by IBRX
- Prepare responses to Health Authority comments and questions pertaining to clinical issues.
- Provide guidance, training, and expert opinion to others in the preparation, analysis, and documentation of studies
Responsibilities
- Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
- Evaluate clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document
- Draft and finalize documents for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, briefing books, and any other application documents.
- Ability to successfully manage multiple changing deadlines and operate in ambiguity
- This desk-based role involves the close study of scientific and regulatory documents.
Requirements
- Bachelor's Degree in life sciences life sciences or technical discipline with 10+ years of relevant progressive experience required
- Master's degree in life sciences or technical discipline with 8+ years of relevant progressive experience required
- Experience in the preparation of the submission of clinical modules in eCTD format required.
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
- Strong knowledge of clinical documentation
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Bachelor's Degree in life sciences life sciences or technical discipline with 10+ years of relevant progressive experience required; or
Skills
- Knowledge, Skills, & Abilities
- Strong organizational skills, written and oral communication skills, and attention to detail
Compensation
- The annual base pay range for this position is below.
Benefits
- Monitor and analyze emerging Health‑Authority guidance to anticipate regulatory shifts and advise cross‑functional teams.
- Familiarity with organizing responses to Health Authority information requests required.
- Familiarity with regulatory submissions outside of the US a bonus
- Strong knowledge of Health Authority clinical guidance documents and requirements
- Health and Financial Wellness Programs
Company info
- We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
- At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.
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
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.