Job Number: 21-05904
Job Number: 21-05904
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Toxicology Writer for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Partner with Project Toxicologists to author, review and track regulatory documents. This would include but is not limited to INDs, NDAs, 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 Toxicologist
- 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
- Pharmaceutical/biotech industry experience of >4 years, Toxicology experience strongly preferred
- First-hand experience as lead author on writing documents for Toxicology 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
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.