Regulatory Medical Writer

14 hours ago


Quebec City, Canada Syneos Health Full time
Job Summary

At Syneos Health, we are seeking a highly skilled Regulatory Medical Writer to join our team. As a Regulatory Medical Writer, you will be responsible for developing and reviewing clinical study protocols, reports, and other regulatory documents. You will work closely with cross-functional teams to ensure that all documents meet regulatory requirements and are of high quality.

Key Responsibilities
  • Develop and review clinical study protocols, reports, and other regulatory documents
  • Collaborate with cross-functional teams to ensure that all documents meet regulatory requirements and are of high quality
  • Conduct literature searches and review relevant scientific literature to support document development
  • Develop and maintain knowledge of regulatory requirements and guidelines, including ICH-E3 and FDA regulations
  • Provide medical writing support for clinical trials, including development of clinical study protocols, reports, and other regulatory documents
Requirements
  • Bachelor's degree in a life science or related field
  • Minimum 2 years of experience in medical writing, regulatory affairs, or a related field
  • Strong knowledge of regulatory requirements and guidelines, including ICH-E3 and FDA regulations
  • Excellent writing and communication skills
  • Ability to work independently and as part of a team
What We Offer
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Recognition and rewards for outstanding performance

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