Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy
Jobs / Job page
Clinical Regulatory Writing Consultant (US or Canada) image - Rise Careers
Job details

Clinical Regulatory Writing Consultant (US or Canada)

Do you have a flair for Clinical Regulatory Writing?If you love writing, have a passion for clinical 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 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.• 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 modules for FDA submissions 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.#LI-REMOTE
Parexel Glassdoor Company Review
4.0 Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon Glassdoor star icon
Parexel DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of Parexel
Parexel CEO photo
Jamie Macdonald
Approve of CEO

We Care Everything we do has the potential to impact patient lives. We show we care by taking our work seriously, demonstrating empathy and acting with heart. Our overarching Guiding Principle that sits across our four core values and translates ...

37 jobs
MATCH
Calculating your matching score...
FUNDING
DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
September 27, 2024

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
Other jobs
Company
Posted 2 months ago
Company
Posted 10 months ago
Company
Posted last year