Clinical and Nonclinical Regulatory Writer (US or Canada)
United States of America, Remote Job ID R0000027920 Category Regulatory / Consulting Date Posted 09/25/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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 Parexel's 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.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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