Principal Specialist, Health Authorities
About The Position
The Principal Specialist, Health Authorities assists in developing global clinical regulatory strategy for investigational and marketed products and prepares, reviews, and finalizes submission packages and responses to Health Authorities. The role provides high-level expertise to ensure regulatory submissions conform to local Health Authority requirements. The position evaluates clinical data and documentation, assembles reports of company-sponsored clinical studies, and drafts and finalizes regulatory submission documents. It also prepares responses to Health Authority questions, supports version-control governance and audit-ready documentation, advises and trains colleagues, and monitors emerging Health Authority guidance. The role is based onsite in Summit, New Jersey, with a regular Monday–Friday schedule during standard business hours and some flexibility with manager approval.
Requirements
- Bachelor’s degree in life sciences or a technical discipline and 10 or more years of relevant progressive experience; or a master’s degree in life sciences or a technical discipline and 8 or more years of relevant progressive experience.
- Experience preparing clinical modules for submission in eCTD format.
- Familiarity with organizing responses to Health Authority information requests.
- Strong 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.
- Ability to manage multiple changing deadlines and operate amid ambiguity.
Nice To Haves
- Familiarity with regulatory submissions outside the United States.
Responsibilities
- Evaluate clinical data, reports, and summaries for compliance with protocols, statistical analysis plans, monitoring guidelines, data management plans, and other clinical-trial documents.
- Assemble reporting for clinical studies sponsored by IBRX.
- Draft and finalize regulatory submission documents, including INDs, CTAs, NDAs, BLAs, MAAs, briefing books, and other application documents.
- Prepare responses to Health Authority comments and questions concerning clinical issues.
- Assist with version-control governance, including overseeing a centralized document repository, applying naming-convention standards, authorizing change-tracking procedures, and assisting with final module versions before electronic upload to ensure audit-ready documentation.
- Provide guidance, training, and expert opinion to others in the preparation, analysis, and documentation of studies.
- Monitor and analyze emerging Health Authority guidance, anticipate regulatory shifts, and advise cross-functional teams.
- Perform ad hoc and cross-functional duties or projects as assigned to support business needs and provide developmental opportunities.
Benefits
- 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.
- 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.
- Eligible for a discretionary bonus and equity award.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
