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Associate Medical Writer - Remote

Posted 3 days ago
Writing
Full Time
Canada

Overview

The Associate Medical Writer is responsible for writing, editing, and reviewing clinical documentation, ensuring compliance with regulatory standards and supporting the quality control process.

In Short

  • Writes and edits informed consent forms and patient information.
  • Finalizes and tracks clinical study report patient safety narratives.
  • Collects documents for CSR appendices.
  • Performs quality control reviews of clinical documents.
  • Acts as a backup contact for project managers.
  • Collaborates with automation teams for narrative development.

Requirements

  • Bachelor's or Master's degree in biomedical or life sciences.
  • Minimum 2 years of experience in medical writing.
  • Experience in pharmaceutical or biotechnology industries.
  • Knowledge of FDA and ICH regulations.
  • Understanding of eCTD requirements.

Benefits

  • Focus on employee well-being and growth.
  • Opportunity to work in a dynamic global company.
  • Engagement in meaningful work that impacts lives.
PSI CRO logo

PSI CRO

PSI CRO is a prominent Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Founded in Switzerland, PSI is a privately owned, full-service CRO that operates globally, supporting clinical trials across various countries and continents. The company is known for its selective approach to project engagement, emphasizing high-quality and timely services across a wide range of therapeutic areas. PSI values diversity and inclusivity within its workforce, fostering an environment where all colleagues feel welcomed and valued. The organization is dedicated to not only conducting clinical trials but also building a community that empowers team members to thrive and contribute to significant advancements in the pharmaceutical sector.

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