Join Parexel as a Clinical Regulatory Writing Consultant! 📊✍️
Are you a wordsmith with a passion for clinical regulatory strategy? 🧬📊
Join our Regulatory Consulting team and shape the future of healthcare from the comfort of your home! 🏠💻
Clinical Regulatory Writing Consultant (US or Canada)
As a 📊Clinical Regulatory Writing ✍️ Consultant, you will:
Be responsible for Regulatory technical writing (clinically focused) to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US submissions, clinical trial applications, and clinical consultation responses for multiple clients.
Qualifications:
RA professional with 4+ yrs experience in clinical development that includes writing of clinical technical documents and a strong understanding of ICH/ E6/ GCP guidelines.
- New INDs
- Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, Meeting Request and Packages
- NDA/BLA submissions
Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
Extensive knowledge of being able to develop product/ therapeutic knowledge in a new area.
Previous Biologics experience is required. Previous device experience is a plus.
Previous experience with oncology or rare disease products is a plus.
Bachelor’s, Master’s or PhD in science/biological or healthcare.
Primarily seeking an experienced Clinical author to support FDA submissions:
You’re our ideal candidate if you have:
- 4+ years in clinical development 📅
- Expertise in FDA submissions (INDs, NDAs, BLAs) 📑
- Biologics experience is required 🧪
- Device knowledge is a plus🔬
Ready to join the Industry’s BEST? Apply now! https://lnkd.in/g29YKF5h 🚀