Regulatory Document Quality Specialist

1 week ago


Bengaluru, Karnataka, India Parexel Full time

Regulatory Document Quality Specialist Role Summary:

This role is focused on providing high-quality document checking services to support the preparation of regulatory documents in the pharmaceutical industry.

Key Responsibilities:

  • Perform quality control checks on documents, including compilation, formatting, tabulation, and pagination.
  • Verify document content and style adhere to FDA/EMA or other regulatory guidelines and departmental SOPs.
  • Collaborate with medical writers to plan, coordinate, and execute complex QC activities.
  • Lead other Document Quality Reviewers in QCs involving multiple documents or requiring specialist knowledge.
  • Provide oversight to ensure quality and consistency across multiple QCs.

Requirements:

  • Excellent written and spoken English skills.
  • Well-established proof-reading skills and high attention to detail.
  • High level of numeracy and understanding of statistics.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to manage multiple tasks, prioritize workload, and work in a solutions-driven manner.

Preferred Qualifications:

  • Experience in the pharmaceutical industry and medical writing.
  • Knowledge of regulatory documents and ICH-GCP guidelines.
  • Advanced word processing skills, including expertise in Word for Windows and document formatting standards.


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