Consultant – Medical Writer
Ividata Life Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Lyon • France
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About the role
- Draft regulatory documents in accordance with internal procedures and EMA and FDA regulatory requirements
- Support teams in clinical submissions for Phase II and Phase III studies
- Prepare Brief Packs and Clinical Briefs for the FDA & EMA
- Draft and/or update Investigator Brochures, INDs & IMPDs
- Prepare PIP waivers and Orphan Drug dossiers
- Ensure cross-functional communication between regulatory, clinical, and medical affairs teams
Requirements
- Proven expertise in drafting regulatory deliverables
- Master’s degree in a scientific, medical, or pharmacy field
- At least 3 years of experience writing clinical regulatory documents
- Regulatory writing skills preferably with FDA experience
- Proficiency in Microsoft Office (Word and PowerPoint); knowledge of Veeva is desirable
- Strong communication, scientific rigor, and autonomy
- English (written & spoken)
Benefits
- Stimulating work environment
- Opportunities for professional development
- Human-centered values
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory writingdrafting regulatory documentsclinical regulatory documentspreparing Brief Packspreparing Clinical Briefsdrafting Investigator BrochuresINDsIMPDsPIP waiversOrphan Drug dossiers
Soft Skills
strong communicationscientific rigorautonomy
Certifications
Master’s degree in scientific fieldMaster’s degree in medical fieldMaster’s degree in pharmacy field