Principal Medical Regulatory Writer

Sanrafaelvet

Barcelona, Spain
Hybrid
Write and edit clinical and safety documents
Support marketing authorization applications
Develop therapeutic area expertise
Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities, in compliance with internal and external standards and guidelines

Job Summary

  • Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities, in compliance with internal and external standards and guidelines.
  • Acts as an Center of Excellence (CoE) leader by disseminating leading-edge knowledge/ best practices, process optimization, and competency in multiple deliverables across various TAs.
  • Effectively coach, guide and mentor medical writers within the team via structured, focused interactions, and using appropriate strategies, tools and techniques for their development.

Matching Summary

Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities, in compliance with internal and external standards and guidelines.

Skills & Requirements

Must-have

  • Write and edit clinical and safety documents
  • Support marketing authorization applications
  • Develop Therapeutic Area expertise
  • Manage end-to-end writing processes
  • Coach and mentor medical writers
  • Expert knowledge of global drug registration

Nice-to-have

  • Integrated and effective communication
  • Process optimization and competency
  • Scientific ecosystem enhancement
  • Agile and knowledgeable across TAs

Key Requirements

  • 12+ years of experience in medical regulatory writing
  • Experience in trainings, mentoring, team management
  • Advanced degree in life sciences/pharmacy/similar discipline or medical degree
  • Excellent knowledge of the English language

Work Rights

Not specified

Tailored Resume

Cover Letter