Senior Medical Regulatory Writer

Sanofi UK

Hyderabad, India
Write and edit safety and clinical documents
Medical sections of periodic benefit-risk evaluation reports
Clinical study reports (csr)
Sanofi Business Operations is an internal Sanofi resource organization based in India, set up to centralize processes and activities to support various Sanofi functions globally

Job Summary

  • Sanofi Business Operations is an internal Sanofi resource organization based in India, set up to centralize processes and activities to support various Sanofi functions globally.
  • The role involves writing and/or editing high-quality safety and clinical documents, including PBRERs, CSRs, and clinical evaluation reports, ensuring compliance with internal and external standards.
  • Sanofi is committed to providing equal opportunities to all individuals, fostering diversity, equity, and inclusion within its workforce.

Matching Summary

Sanofi Business Operations is an internal Sanofi resource organization based in India, set up to centralize processes and activities to support various Sanofi functions globally.

Skills & Requirements

Must-have

  • Write and edit safety and clinical documents
  • Medical sections of Periodic Benefit-Risk Evaluation Reports
  • Clinical Study Reports (CSR)
  • Product and Disease ID Cards
  • Clinical evaluation reports
  • Trial transparency documents
  • ICH and GCP/GVP knowledge

Nice-to-have

  • Act as buddy or mentor
  • Develop TA expertise
  • Collaborate with global teams
  • Maintain effective stakeholder relationships
  • Pursue progress and discover extraordinary

Key Requirements

  • >5 years of experience in regulatory writing
  • Excellent English language skills
  • Ability to summarize scientific information

Work Rights

Not specified

Tailored Resume

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