Contingent Worker - Senior Regulatory Clinical Science Specialist

ImmunityBio; Summit (NJ); On-site; USD 100,000 - 125,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Temporary Senior Regulatory Clinical Science Specialist to contribute to the development of global clinical regulatory strategies. This role offers the opportunity to work with cutting-edge technology aimed at transforming cancer treatment through immunotherapy. You will be responsible for drafting critical regulatory documents and ensuring compliance with health authority requirements. Join a collaborative team where your expertise will help shape the future of cancer therapies and vaccines, all while enjoying a supportive work environment that prioritizes your professional development.

Benefits

Medical, Dental and Vision Plan Options

Health and Financial Wellness Programs

Employer Assistance Program (EAP)

Company Paid Life/AD&D Insurance

401(k) Retirement Plan with Company Match

Unlimited Paid Time Off for Exempt Employees

Paid Time Off (PTO) including 11 Holidays

Voluntary Legal Services

Identity Theft Protection

Employee Discounts and Rewards

Qualifications

• 7+ years of regulatory clinical science experience required.
• Expertise in clinical research and regulatory guidelines is essential.

Responsibilities

• Draft essential BLA documents and assist in regulatory submissions.
• Review clinical data for compliance and provide regulatory input.

Skills

Regulatory Compliance

Clinical Research

Good Clinical Practices

Document Management

Communication Skills

Organizational Skills

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Tools

eCTD Submission Software

DocuBridge

Job description

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.

Why ImmunityBio?
* ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
* Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
* Work with a collaborative team with the ability to work across different areas of the company.
* Ability to join a growing company with professional development opportunities.

Position Summary

The Temporary Senior Regulatory Clinical Science Specialist will report to the Director, Regulatory Clinical Science and is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format. This role will provide a high-level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements.

Essential Functions

• Draft essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing and reconciliation.
• Review, edit and approve all final submissions in DocuBridge
• Assist in daily operations outside of essential BLAs, including protocol reviews / amendments, provide regulatory input on day-to-day issues, and provide regulatory documents to other departments
• 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 by IBRX or by CROs
• Draft written summaries for regulatory submissions including INDs, NDAs, and BLAs
• Prepare or review documents including 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

Education & Experience

• Bachelor's degree in life sciences or a related field required; 7+ years of relevant regulatory clinical Science experience is required
• Or Master's degree in life sciences or a related field required; 5+ years of relevant regulatory clinical Science experience is required
• Mid-level regulatory or clinical operation expertise preferred
• Experience in the preparation of the submission of clinical modules in eCTD format is preferred
• Familiar with organizing responses to Health Authority information requests si preferred
• Familiarization with regulatory submissions internationally is preferred.

Knowledge, Skills, & Abilities

• 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 with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written and oral communication skills, and attention to detail

Working Environment / Physical Environment

• This is a full-time position (40 hours per week) on-site (Monday through Friday).
• A Senior Regulatory Clinical Science Specialist may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• They will work closely with scientific colleagues throughout the day, often on a project-team basis.
• Lift and carry materials weighing up to 20 pounds.

$67.50 (entry-level qualifications) to $75.00 (highly experienced) hourly

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term 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 and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 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 * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to 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.