ImmunityBio
Senior Specialist, Health Authorities
Summit, NJ · Senior
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About the role
- The Senior Specialist, Health Authorities will assist in the development of global clinical regulatory strategy for investigational and marketed products and assist with the preparation of dossiers in eCTD format.
- Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan
- Assemble the reporting of clinical studies performed sponsored by IBRX
Responsibilities
- Provide support and training to others in the preparation, analysis, and documentation of studies
Requirements
- Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
- Strong knowledge of clinical documentationAbility to work with firm deadlines and adapt quickly to changing requirements and priorities
Skills
- Knowledge, Skills, & Abilities
- Strong organizational skills, written and oral communication skills, and attention to detail
- ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions.
- These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach.
Compensation
- The annual base pay range for this position is below.
- $145,000 (entry-level qualifications) to $160,000 (highly experienced) annually
- Prepare or review documents including investigator brochures, pharmacy manuals, protocols, clinical study reports, annual reports, DSURs, and clinicaltrials.gov entries, etc.
Benefits
- Familiarity with organizing responses to Health Authority information requests
- Familiarity with regulatory submissions outside of the US a bonus
- Knowledge of Health Authority clinical guidance documents and requirements
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
This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.