Senior Specialist, Health Authorities
About The Position
The Senior Specialist, Health Authorities assists in developing global clinical regulatory strategy for investigational and marketed products and preparing dossiers in eCTD format. The role provides expertise to help ensure clinical trials conform to Health Authority requirements. It reviews clinical data and documentation, supports clinical study reporting, drafts regulatory submission summaries, prepares or reviews clinical and regulatory documents, and provides support and training to colleagues. The position is based on site in Summit, New Jersey, and follows a regular Monday–Friday schedule during standard business hours, with flexibility available with manager approval.
Requirements
- Bachelor’s degree in life sciences or a technical discipline and 7 or more years of relevant progressive experience, or a master’s degree in life sciences or a technical discipline and 5 or more 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 communication, and oral communication skills, with attention to detail.
Nice To Haves
- Familiarity with organizing responses to Health Authority information requests.
- Familiarity with regulatory submissions outside the United States.
Responsibilities
- Review clinical data, reports, and summaries for compliance with protocols, statistical analysis plans, monitoring guidelines, and data management plans.
- Assemble reporting for clinical studies sponsored and performed 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.
- Provide support and training to others in the preparation, analysis, and documentation of studies.
- Assist in developing global clinical regulatory strategy for investigational and marketed products.
- Assist with preparing dossiers in eCTD format and help ensure clinical trials conform to Health Authority requirements.
Benefits
- Discretionary bonus and equity award eligibility.
- Medical, dental, and vision plan options.
- Health and financial wellness programs.
- Employer Assistance Program (EAP).
- Company-paid and voluntary life and AD&D insurance.
- Short-term and long-term disability coverage.
- 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, and 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
