Regulatory Document Specialist

11 hours ago


Cambridge, Cambridgeshire, United Kingdom VCLS Full time
Job Overview

We are seeking a highly skilled Regulatory Document Specialist to join our team at VCLS. As a key member of the team, you will be responsible for creating high-quality medical documents for various client projects.

The ideal candidate will have a strong background in regulatory affairs and excellent writing skills. You will work closely with cross-functional teams, including scientists, researchers, and regulatory affairs professionals.

Key Responsibilities:

  • Authoring clinical and regulatory documents, including study protocols, investigator brochures, and clinical study reports.
  • Reviewing draft and final documents prepared by VCLS consultants or clients, ensuring accuracy, consistency, and adherence to regulatory standards.

Requirements:

  • Minimum 5+ years of experience as a Medical Writer in the pharmaceutical or biotech industry.
  • Bachelor's degree or higher in a scientific discipline.
  • Regulatory expertise and strong understanding of ICH guidelines and regulatory requirements.

Estimated Salary: $95,000 - $115,000 per year, depending on qualifications and experience.



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