Job Details

  • Title: Toxicology Writer
  • Code: RCI-35140-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 01/26/2021
  • Duration: 12 Months
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  Job Description

  • 1. Partner with Project Toxicologists to author, review and track regulatory documents. This would include but is not limited to INDs, NDAs, CTD, IBs, etc.
  • 2. Be able to work on multiple projects across all modalities including small molecule, large molecule and cell therapies.
  • 3. Address Health Authority questions pertaining to nonclinical Toxicology with the Project Toxciologist.
  • 4. Complete regular document updates such as IB, DSUR, ODAR etc. for the Project Toxicologist.
  • 5. Track documents through review cycles. Attend department group meetings as needed to be informed of upcoming needs for nonclinical documentation.
  • 6. Understand the impact of Toxicology on other functions within the company such as Clinical and CMC.
Skills/Knowledge Required:
  • Pharmaceutical/biotech industry experience of >4 years, Toxicology experience strongly preferred.
  • First-hand experience as lead author on writing documents for Toxciology to be submitted to global regulatory agencies.
  • Strong PC experience:
    • Training on in-house document repository system will be provided.
    • Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.
  • Must be flexible and adaptable to changing project priorities and work assignments.
  • Must have strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required.
  • Careful attention to detail and quality are essential.
  • Excellent Toxicology writing and verbal communication skills required.