Document Quality Management, Associate Director

Novartis

Hyderabad, India
Electronic document management systems
Document review expertise
Clinical and nonclinical submission dossiers
This role provides business leadership on document quality management and drives compliance and efficiency for Biomedical Research submissions to Regulatory Affairs

Job Summary

  • This role provides business leadership on document quality management and drives compliance and efficiency for Biomedical Research submissions to Regulatory Affairs.
  • The Associate Director leads qualification and oversight of external service providers and manages document migration and integration projects related to global mergers and acquisitions.
  • They represent the Document Quality Management department in audits and inspections and lead initiatives to improve processes and implement new systems and tools.

Matching Summary

This role provides business leadership on document quality management and drives compliance and efficiency for Biomedical Research submissions to Regulatory Affairs.

Skills & Requirements

Must-have

  • electronic document management systems
  • document review expertise
  • clinical and nonclinical submission dossiers
  • project leadership and management
  • compliance with GxPs and SOPs
  • cross-functional team collaboration
  • Microsoft Office proficiency

Nice-to-have

  • data analysis
  • process improvement
  • regulatory compliance knowledge
  • proactivity
  • strong communication and presentation skills
  • customer centricity
  • experience in matrix environment

Key Requirements

  • Undergraduate degree or equivalent experience
  • 5+ years relevant experience
  • Fluent oral and written English

Work Rights

Not specified

Tailored Resume

Cover Letter