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

resume

to:

Farhan@NaseejConsulting.com

Job Types: Full-time, Contractual / Temporary

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

Work Location: Remote