Quality Control Senior Associate

Job Summary

To support the Strategic Medical Writing Operations Team, the full-time Quality Control Senior Associate will manage quality control activities for clinical and regulatory documents, ensuring accuracy and compliance while mentoring junior staff in a remote work environment.

Key responsibilities

• Conduct independent quality control reviews of clinical regulatory documents against source documents
• Maintain and oversee quality control documentation processes, ensuring completeness and accuracy
• Lead the development and implementation of medical writing operations business processes and provide training to contractors

Required qualifications

• Bachelor's degree required, preferably in Science, English, or Communication
• 3-4 years of relevant industry experience in quality control or related fields such as clinical research or regulatory affairs
• Project management experience preferred
• Excellent knowledge of clinical documents and eCTD structure, along with global regulatory requirements
• Proficiency in Microsoft Office Products and familiarity with publishing software and content management systems