Job Details

Talk to our Recruiter

Back to Listing

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.

Apply Create Job Alert