Medical Writer

Eclaro

Freelance (Ongoing)

Sep 7

This job is no longer accepting applications.

Job Description

Responsibilities:

  • 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:

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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