Medical Writer (Regulatory & Clinical)

Job Description

We are seeking experienced Medical Writers (Regulatory & Clinical) to support U.S.-based biotech and pharmaceutical clients. This is a remote opportunity involving the preparation of regulatory and clinical trial documentation for global development programs.

You will work on high-impact deliverables supporting IND, NDA, BLA, and EU submissions, collaborating with cross-functional clinical, regulatory, and biometrics teams.

This role is ideal for candidates with strong scientific writing skills and direct experience in clinical research and regulatory documentation.

Key Responsibilities

• Author and review clinical trial protocols, IBs, and ICFs
• Prepare Clinical Study Reports (CSRs)
• Draft ISS/ISE sections and regulatory summaries
• Support FDA and EMA submission modules (CTD format)
• Write safety narratives and clinical summaries
• Ensure documents comply with ICH, GCP, FDA, and EMA guidelines
• Collaborate with biostatistics, data management, and clinical teams
• Manage timelines and deliverables across multiple projects

Required Qualifications

• Master’s or PhD in Life Sciences, Pharmacy, Medicine, or related field
• 3+ years of experience in regulatory or clinical medical writing
• Hands-on experience with CSRs, protocols, and regulatory submissions
• Strong understanding of ICH, GCP, FDA, EMA guidelines
• Excellent written English and attention to detail
• Ability to work independently in a remote environment

Preferred Experience

• Oncology, rare disease, or specialty therapeutics
• Experience supporting IND/NDA/BLA submissions
• CRO or global pharma/biotech experience
• Familiarity with document management systems (Veeva, Vault, etc.)

Work Model

• 100% Remote
• Based in India
• Long-term engagement for strong performers
• Exposure to U.S. and EU regulatory programs

Compensation

• Competitive compensation based on experience
• Paid monthly
• Growth opportunities into Senior or Lead Medical Writer roles

How to Apply

Please email your résumé to:
Farhan@NaseejConsulting.com

Job Types: Full-time, Contractual / Temporary

Pay: ₹12,785.51 - ₹41,483.54 per month

Work Location: Remote