Clinical and Nonclinical Regulatory Writer (US or Canada)

Do you have a flair for Regulatory Writing?

If you love writing, have a passion for clinical and nonclinical regulatory strategy, have experience with biologics, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience and working with some of the Industry’s BEST, then Parexels Regulatory Consulting team has an amazing opportunity for you!

As a Clinical/Nonclinical Regulatory Writer, You Will

Be responsible for Regulatory technical writing 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 experience in clinical development that includes 4+ years experience writing clinical and nonclinical technical documents and a strong understanding of ICH/E6/GCP guidelines.

Primarily seeking an experienced Clinical author to support FDA submissions:

• 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 experience independently authoring clinical and nonclinical modules for FDA submissions to include 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 is required. EU submissions experience is a plus.
• 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.