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- Partner with Project Toxicologists to author, review and track regulatory documents. This would include but is not limited to INDs, CTA's, NDAs, BLA's, CTD, IBs, etc.
- Be able to work on multiple projects across all modalities including small molecule, large molecule and cell therapies.
- Address Health Authority questions pertaining to nonclinical Toxicology with the Project Toxciologist.
- Complete regular document updates such as IB, DSUR, ODAR etc. for the Project Toxicologist.
- Track documents through review cycles. Attend department group meetings as needed to be informed of upcoming needs for nonclinical documentation.
- Understand the impact of Toxicology on other functions within the company such as Clinical and CMC.
- Other duties related to the above within Client, as assigned.
- First-hand experience as lead author on writing documents for Toxicology to be submitted to global regulatory agencies.
- Pharmaceutical/biotech industry experience of 0-3 years, Toxicology is preferred.
- Life science degree in appropriate field
- Strong PC experience:
o Training on in-house document repository system will be provided.
o 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 writing and verbal communication skills required.
Contract length: 12 months
Job Types: Full-time, Contract
Salary: $50.00 per hour
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