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Medical Writer

  • Location: New Brunswick
  • Job Type:Contract

Posted 30 days ago

  • Expiry Date: 29 November 2021

Job Description:

JOB TITLE: Nonclinical Scientific Writer - Toxicology

Responsibilities include:

  • 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.

Skills/Knowledge Required:

  • 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.