Regulatory Affairs Expert for Clinical and Nonclinical Documents

7 days ago


Nova Scotia, Canada Parexel Full time

About Us

Parexel is a global leader in clinical research, providing innovative solutions to advance drug development. We are committed to delivering exceptional quality, efficiency, and patient safety.

Job Title: Clinical and Nonclinical Regulatory Writer

Estimated Salary: $90,000 - $120,000 per year

Job Description:

We are seeking an experienced Clinical and Nonclinical Regulatory Writer to join our team. As a key member of our regulatory consulting team, you will be responsible for creating high-quality regulatory documents to support the development of clinical trials.

Responsibilities:

  • Develop and maintain regulatory technical writing skills to create clinical and nonclinical documents in accordance with ICH/E6/GCP guidelines.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies to support clinical trial submissions.
  • Analyze data and provide objective advice on regulatory requirements to ensure compliance with FDA regulations.
  • Author clinical and nonclinical modules for FDA submissions, including experience authoring 2.4, 2.5, 2.6, 2.6.2, 2.6.4, 2.6.6, 2.7, 2.7.3, and 2.7.4.
  • Support EU submissions and have previous biologics experience.

Requirements:

  • Bachelor's, Master's, or PhD in science, biological, or healthcare fields.
  • Minimum 4 years of experience in clinical development, including experience writing clinical and nonclinical technical documents.
  • Strong understanding of ICH/E6/GCP guidelines and ability to interpret data objectively.

What We Offer:

  • Competitive salary range: $90,000 - $120,000 per year.
  • Ongoing training and professional development opportunities.
  • Diverse and inclusive work environment.
  • Flexible working arrangements to balance work and personal life.


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