Job Title: Regulatory Writing & Submission Support – SME Required
Job Type: Regulatory Content Support / Medical Writing
Project Urgency: High / Critical Requirement
Work Mode: Remote (with location restrictions)
Project Overview
We have received a requirement for regulatory content support and are looking to align an experienced Subject Matter Expert (SME) with strong expertise in regulatory writing and submission packages.
Key Requirements
The ideal resource should have:
Strong experience in regulatory writing and submission documentation
SME-level, hands-on exposure to:
Strategy & Argumentation (STRG ARG) submissions
ADRG, SDRG, and ADaM-related documentation
Proven ability to use accurate regulatory language and medical terminology
Familiarity with applicable regulatory guidelines and standards
⚠️ Location Restriction:
This task cannot be performed in China.
Eligible resources must be based in:
India
Singapore
Hong Kong
Or Chinese nationals located outside China
Scope of Work
ADRG: ~10 studies
SDRG: ~10 studies
ADaM datasets: ~20–25 variables
Document Length: Approximately 2–3 pages per document
If interested then please share your updated CV to [email protected]
Hope to hear from you soon.
Regards
