Documentation Quality Control Specialist

Idorsia Pharmaceuticals Ltd

Basel, Switzerland
On-site
Review clinical and regulatory documents
Ensure document suitability for submissions
Improve document quality
Idorsia Pharmaceuticals Ltd is seeking a Documentation Quality Control Specialist to join its Drug Regulatory Affairs Function in Basel, Switzerland. The role involves reviewing clinical and regulatory documents to ensure compliance with guidelines and quality standards, while also mentoring and managing external consultants

Job Summary

  • Reviews clinical and regulatory documents to ensure clarity, conciseness, consistency, completeness, and adherence to guidelines.
  • Interacts with authors and contributors to continuously improve document quality and contributes to the development of templates and guidelines.
  • Manages external consultants, allocating work and ensuring timely, quality deliverables, while also coaching and mentoring.

Matching Summary

Match Score: 85

Idorsia Pharmaceuticals Ltd is seeking a Documentation Quality Control Specialist to join its Drug Regulatory Affairs Function in Basel, Switzerland. The role involves reviewing clinical and regulatory documents to ensure compliance with guidelines and quality standards, while also mentoring and managing external consultants.

Skills & Requirements

Must-have

  • Review clinical and regulatory documents
  • Ensure document suitability for submissions
  • Improve document quality
  • Develop documentation templates and guidelines
  • Manage external consultants

Nice-to-have

  • Foster respect, fairness, and equal opportunities
  • Harness the power of difference, authenticity, and inclusion

Key Requirements

  • At least 2 years previous experience
  • Postgraduate qualification in a science-related field
  • Excellent spoken and written English
  • Knowledge of regulatory document requirements/guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter