Clinical Regulatory Content Specialist

6 days ago


Durham, North Carolina, United States Lifelancer Full time

About the Role

We are seeking a highly skilled Clinical/Nonclinical Regulatory Writer to join our team at Lifelancer. As a key member of our Regulatory Consulting group, you will be responsible for creating high-quality regulatory technical documents in accordance with ICH/E6/GCP guidelines to support US submissions, clinical trial applications, and clinical consultation responses for multiple clients.

Key Responsibilities

  • Create clinical and nonclinical technical documents, including INDs, Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, Meeting Request and Packages, NDA/BLA submissions
  • Interpret data and advise from regulatory authorities objectively, often in the face of strongly held competing views
  • Develop product/therapeutic knowledge in new areas
  • 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
  • Prioritize tasks to meet project deadlines

Requirements

  • 4+ years experience writing clinical and nonclinical technical documents
  • Strong understanding of ICH/E6/GCP guidelines
  • RA professional with experience in clinical development
  • Bachelor's, Master's or PhD in science/biological or healthcare
  • Previous Biologics experience required, Previous device experience is a plus
  • Previous experience with oncology or rare disease products is a plus

Salary Estimate: $120,000 - $180,000 per year

About Us

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. We are committed to providing top-notch services to our clients and employees alike.



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