Consultant – Medical Writer

Ividata Life Sciences

Medical Writer role at IVIDATA Life Sciences, focusing on clinical document preparation and submissions. Leveraging expertise in regulatory writing for pharmaceutical and biotechnology clients.

Posted 4/17/2026full-timeLyon • 🇫🇷 FranceMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Stimulating work environment
Opportunities for professional development
Human-centered values

ATS Keywords

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Applicant Tracking System Keywords

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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