Agency Temporary

2 weeks ago

Summit, NJ, United States ImmunityBio Full time

NantWorks (the "Company") is the parentcompany of various private and public entities that are changinghow we work, live and play. We focus on three main categories: lifesciences; energy & renewables; and media & technology. We investin strategies that improve our core capabilities and in brandnew industries, poised to change mankind for the better. Bycapturing tomorrow's opportunities through scientific processes andentrepreneurial philosophies, we are at the forefront of emerginghigh-growth technologies across a wide range of industries.

The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Companymay also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Position Summary

The Contingent Worker- Regulatory Clinical Science Specialist will report to the Director, Regulatory Clinical Science and be responsible for contributing to the maintenance of global clinical regulatory compliance for investigational and marketed products and contribute towards the maintenance of study files in eCTD format. This position will support the organization in the management and conduct of clinical programs, focusing on accurately and efficiently filing appendices in clinical study reports and maintaining files to ensure ongoing compliance with regulatory requirements.

Essential Functions

  • Accurately and efficiently file documents for Appendix 16.1.4 and 16.1.5 of the clinical study report for all active clinical studies
  • Ensure that all documents are properly labeled, dated, and stored in accordance with company policies and regulatory requirements
  • Help with filing documents for closing clinical studies, ensuring that all necessary appendices are accounted for and properly stored in accordance with ICH E3 guidance
  • Maintain accurate records of filed documents, including updating tracking systems and databases as needed
  • Collaborate with team members to ensure that documents are filed and formatted correctly and that any issues are resolved promptly
  • Create and maintain project plans
  • Create, edit and adhere to Standard Operating Procedures (SOPs).
  • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.


Education & Experience

  • Bachelor's degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required ; OR
  • Master's degree in life sciences or a related field required; 2+ 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 is preferred
  • Familiarization with regulatory submissions internationally is preferred.

Knowledge, Skills, & Abilities

  • Knowledge of Health Authority clinical guidance documents and requirements
  • Knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines
  • Strong Attention to detail
  • Strong knowledge of clinical documentation and terminology
  • 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.
  • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
  • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
  • This desk-based role involves 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.

The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$40.00 (entry-level qualifications) to $45.00 (highly experienced) per hour

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

This is the pay range the Company reasonably expects to pay for this position at thetime of this posting. Compensation will be determined based on the skills,qualifications, and experience of the applicant along with the requirements of theposition.

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