Senior Director, Head of Regulatory Writing

1 day ago


San Francisco, California, United States BioSpace, Inc. Full time
Job Overview

We are seeking a highly experienced Senior Director, Head of Regulatory Writing to lead our regulatory writing team. The successful candidate will have a strong background in oncology clinical research and regulatory writing, with a proven track record of leading cross-functional teams and delivering high-quality regulatory documents.

Key Responsibilities
  • Lead the development of regulatory writing strategies and plans for key projects
  • Provide guidance and oversight to regulatory writers and contractors
  • Review and edit regulatory documents to ensure accuracy and quality
  • Collaborate with cross-functional teams to ensure timely delivery of regulatory documents
  • Develop and maintain regulatory writing processes and templates

Requirements
  • BS with 15+ years of experience in oncology clinical research and regulatory writing, or MS or other advanced science degree with 10+ years of experience
  • Proven experience leading a regulatory writing team and delivering high-quality regulatory documents
  • Strong knowledge of regulatory requirements and guidelines, including GCP and ICH
  • Excellent communication and leadership skills

About Us

Nurix Therapeutics, Inc. is a biopharmaceutical company committed to developing innovative therapies for cancer and other diseases. We are dedicated to advancing the field of oncology and improving patient outcomes through our research and development efforts.

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