Medical Writer I / Medical Writer II

ParexelBellandur, BangalorePosted 18 days ago

Mid level
Full time
2 to 4 years

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About the role

Parexel provides clinical development and consulting services to life sciences companies, including pharmacovigilance and patient safety work. The medical writer prepares regulatory safety documents, assesses safety signals, reviews literature and supports client and compliance activities.

What you'll do

Prepare periodic and ad-hoc regulatory safety reports
Analyze safety data and identify potential signals
Write signal assessments and summarize safety literature
Maintain signal logs, data integrity and audit-ready documentation
Support risk management plans and regulatory compliance
Manage client reviews and mentor junior writers for Medical Writer II

Skills

Must have

Medical writing
Pharmacovigilance
Signal detection
Safety data analysis
Global pharmacovigilance regulations
Medical terminology

Nice to have

Clinical research
Clinical assessment
Therapeutic area expertise
Regulatory submissions

Tools

Meddra
Who-dd
Ms office

Who it's for

Education: Bachelor's degree
Degree: life sciences, health sciences, biomedical sciences, pharmacy, microbiology, biochemistry, biotechnology, biophysics, dentistry, physiotherapy
Experience: 2 to 4 years
Domain: clinical research