- Expiry Date: 07 October 2021
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 BMS, 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
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 writing and verbal communication skills required.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.