Senior Document Quality Reviewer

2 weeks ago


Bengaluru, Karnataka, India Parexel Full time

Job Summary:

Parexel is seeking a skilled Senior Document Quality Reviewer to provide support for the preparation of regulatory documents through the provision of document quality checking services.

Key Responsibilities:

  • Perform quality control (QC) checks, including the compilation, formatting, tabulation and pagination of documents.
  • Perform editorial and format QC of documents.
  • Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs, templates and style guidelines.
  • Work with medical writers to plan, coordinate and execute complex QC activities.
  • Lead other DQRs in QCs split due to size or complexity, or in QCs involving multiple documents.

Requirements:

  • Experience in the pharmaceutical industry and medical writing.
  • Knowledge of regulatory documents and ICH-GCP guidelines.
  • Proof reading, quality control and copy editing experience essential.
  • Advanced word processing skills.
  • Expertise in Word for Windows, including creation and adaptation of document templates.

Education:

  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.


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