Senior Specialist, Health Authorities

ImmunityBio•Summit, NJ

22d•Onsite

About The Position

The Senior Specialist, Health Authorities assists in developing global clinical regulatory strategy for investigational and marketed products and prepares dossiers in eCTD format. The role provides expertise to help ensure clinical trials are conducted in accordance with Health Authority requirements. The position is based on site in Summit, New Jersey, and works closely with scientific colleagues, often on project teams, to study scientific and regulatory documents.

Requirements

Bachelor’s degree in life sciences or a technical discipline and at least 7 years of relevant progressive experience, or a master’s degree in life sciences or a technical discipline and at least 5 years of relevant progressive experience.
Experience preparing clinical modules for submission in eCTD format.
Knowledge of Health Authority clinical guidance documents and requirements.
Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines.
Strong knowledge of clinical documentation.
Ability to work to firm deadlines and adapt quickly to changing requirements and priorities.
Strong organizational, written and oral communication, and attention-to-detail skills.

Nice To Haves

Familiarity with organizing responses to Health Authority information requests.
Familiarity with regulatory submissions outside the US.

Responsibilities

Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan.
Assemble reporting for clinical studies sponsored by IBRX.
Draft written summaries for regulatory submissions, including INDs, NDAs, and BLAs.
Prepare or review investigator brochures, pharmacy manuals, protocols, clinical study reports, annual reports, DSURs, and clinicaltrials.gov entries.
Support and train others in the preparation, analysis, and documentation of studies.

Benefits

Discretionary bonus and equity award.
Medical, dental, and vision plan options.
Health and financial wellness programs.
Employer Assistance Program (EAP).
Company-paid and voluntary life/AD&D insurance and short- 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, employee discounts, rewards, and perks.
Paid time off, including 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.