Expert Medical Regulatory Writer

Sanrafaelvet

Barcelona, Spain
€60.000,00 - €80.000 ph
Hybrid
Clinical and safety documents
Submission to regulatory authorities
Complex clinical study reports
Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities

Job Summary

  • Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities.
  • Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines.
  • Works independently on documents acting as an SME on clinical deliverables, buddy or mentor to the medical and senior medical writers, efficiently peer reviews providing Scientific inputs.

Matching Summary

Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities.

Salary

€60.000,00 - €80.000

Skills & Requirements

Must-have

  • clinical and safety documents
  • submission to regulatory authorities
  • complex Clinical Study Reports
  • complex CTD submission documents
  • Risk Management Plans
  • responses to Health Authorities Queries
  • therapeutic area expertise

Nice-to-have

  • agile and knowledgeable
  • collaborates effectively
  • maintain effective relationships
  • develop medical regulatory content

Key Requirements

  • ≥8 years of experience in regulatory writing
  • 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