Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Senior Medical Writer Ii – Remote Medical Writing Job In India

Propharma
Propharma
6+ years
Not Disclosed
India
1 May 7, 2026
Job Description
Job Type: Full Time Hybrid Remote Education: None Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Medical Writer II – Remote Medical Writing Job in India

Company: ProPharma
Job Title: Senior Medical Writer II
Location: India
Job Type: Full-Time
Work Mode: Remote / Hybrid
Industry: Medical Writing, Clinical Research, Regulatory Affairs, Pharmacovigilance
Job ID: JR 7810

Source:


About ProPharma

ProPharma is a global life sciences consulting organization supporting pharmaceutical, biotechnology, and medical device companies throughout the product lifecycle. With expertise in regulatory sciences, clinical research, pharmacovigilance, quality compliance, and medical information, ProPharma helps healthcare innovators accelerate product development and regulatory success worldwide.


Job Overview

ProPharma is seeking an experienced Senior Medical Writer II to join its growing medical writing team in India. The role focuses on developing high-quality clinical, regulatory, safety, and scientific documents for pharmaceutical, biologic, and medical device programs.

The selected candidate will work closely with cross-functional stakeholders including regulatory affairs, clinical operations, biostatistics, and data management teams to support global clinical research and regulatory submission projects.

This opportunity is ideal for professionals with strong expertise in:

  • Clinical Regulatory Writing
  • Safety Documentation
  • Medical Device Documentation
  • IND/NDA/BLA Submission Writing
  • Clinical Study Reports
  • Pharmacovigilance Documentation

Experience Required

Required Experience

  • Minimum 6 years of experience in:
    • Medical Writing
    • Regulatory Writing
    • Clinical Documentation
    • Safety Writing

Industry Background

Candidates should have prior experience working in:

  • CROs
  • Pharmaceutical Companies
  • Biotechnology Organizations
  • Medical Device or Diagnostics Companies

Freshers Eligibility

  • Freshers are not eligible
  • This is a senior-level medical writing position requiring extensive industry experience

Source:


Educational Qualification

Candidates should possess:

  • Bachelor’s degree or higher in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Medicine
    • Scientific or Healthcare-related disciplines

Advanced scientific or medical education is preferred.


Key Responsibilities

Clinical & Regulatory Writing

Develop and edit:

  • Clinical Study Protocols
  • Protocol Amendments
  • Clinical Study Reports (CSRs)
  • Investigator Brochures (IBs)
  • Informed Consent Forms (ICFs)
  • Patient Narratives
  • DSURs
  • Plain Language Summaries
  • CEPs/CERs

Advanced Regulatory Documentation

Prepare complex regulatory submission documents including:

  • IND
  • NDA
  • BLA
  • MAA
  • PBRER
  • eCTD Submission Documents

Project Management

  • Manage document timelines and deliverables
  • Coordinate QC reviews and audit trails
  • Conduct client meetings and project discussions
  • Support multiple writing projects simultaneously

Cross-Functional Collaboration

Collaborate with:

  • Clinical Operations
  • Biostatistics
  • Regulatory Affairs
  • Data Management
  • Subject Matter Experts

Compliance & Quality

Ensure compliance with:

  • FDA Guidelines
  • ICH E3/E6(R2)
  • EU MDR/IVDR
  • Company SOPs
  • Client Templates and Standards

Required Skills

Technical Skills

  • Medical Writing
  • Clinical Writing
  • Regulatory Writing
  • Safety Documentation
  • IND/NDA/BLA Writing
  • eCTD Submission Preparation
  • Clinical Trial Documentation
  • Medical Device Writing
  • FDA & ICH Guidelines

Software Skills

  • Microsoft Word
  • MS Office Suite
  • Document Formatting
  • Tables, Listings & Figures Management

Soft Skills

  • Project Management
  • Scientific Communication
  • Client Interaction
  • Time Management
  • Attention to Detail
  • Analytical Thinking
  • Team Collaboration

Regulatory Knowledge Required

Strong understanding of:

  • FDA Regulatory Guidelines
  • ICH Guidelines
  • Clinical Research Standards
  • Pharmacovigilance Documentation
  • Regulatory Submission Processes
  • Medical Device Regulations

Why Join ProPharma

  • Work with leading global pharmaceutical and biotech clients
  • Exposure to international regulatory submission projects
  • Flexible remote and hybrid work opportunities
  • Strong career growth and professional development
  • Collaborative and inclusive workplace culture
  • Opportunity to work across multiple therapeutic areas