Regulatory Affairs Expert for Clinical and Nonclinical Documents
7 days ago
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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