Clinical Regulatory Writing Specialist

1 month ago

Toronto, Ontario, Canada Parexel Full time
Unlock Your Potential as a Clinical Regulatory Writing Consultant

About the Role

Parexel's Regulatory Consulting team is seeking a highly skilled Clinical Regulatory Writing Consultant to join our dynamic team. As a key member of our team, you will be responsible for creating high-quality clinical documents that support the development of life-changing therapies.

Key Responsibilities

  • Develop regulatory technical writing to support clinical documents in accordance with ICH/E6/GCP guidelines.
  • Collaborate with cross-functional teams to ensure timely and accurate submissions to regulatory authorities.
  • Provide expert advice on regulatory strategy and document development.
  • Stay up-to-date with regulatory requirements and guidelines to ensure compliance.

Qualifications

  • 4+ years of experience in clinical development with a strong understanding of ICH/E6/GCP guidelines.
  • Proven track record of successfully authoring clinical modules for FDA submissions.
  • Extensive knowledge of regulatory affairs and clinical development processes.
  • Ability to interpret data and provide objective advice.
  • Bachelor's, Master's, or PhD in a science or healthcare-related field.

What We Offer

Parexel is an equal opportunity employer and offers a dynamic work environment, competitive compensation, and opportunities for professional growth and development.

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