Document Quality Management, Associate Director

Stellen Nordrhein Westfalen

Electronic document management systems
Document review expertise
Submission dossier understanding
Provide business leadership and oversight over a broad area of expertise on projects related to public facing or submission documents and/or systems and tools

Job Summary

  • Provide business leadership and oversight over a broad area of expertise on projects related to public facing or submission documents and/or systems and tools.
  • Lead qualification, procurement and quality oversight of external service providers, such as health literacy writers, medical writers, QC reviewers, document publishers and/or data managers.
  • Identify, explore and implement new systems and tools that prove to be suitable for the benefit of S&D by increasing efficiency and/or accuracy.

Matching Summary

Provide business leadership and oversight over a broad area of expertise on projects related to public facing or submission documents and/or systems and tools.

Skills & Requirements

Must-have

  • electronic document management systems
  • document review expertise
  • submission dossier understanding
  • leadership and project management
  • cross-functional team influence
  • GxPs and Standard Operating Procedures

Nice-to-have

  • health literacy principles
  • clinical transparency principles
  • process improvement initiatives
  • customer centricity
  • proactive problem solving

Key Requirements

  • 5+ years in relevant discipline
  • Undergraduate degree in scientific discipline or equivalent
  • Expert level relevant job experience
  • Advanced understanding of submission dossier
  • Proven leadership skills
  • Ability to work in matrix environment
  • Fluent oral and written English

Work Rights

Not specified

Tailored Resume

Cover Letter