We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.

Responsibilities

- Writing high quality CTD modules nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) as per requirements in EU submission
- Response to clinical deficiencies
- Assist with drug development strategy
- SmPC, Patient information leaflet, CCDS updates, Safety variations
- Clinical study reports, Study design and synopsis
- Assist in clinical development strategy Review of Study reports published papers
- Literature search and regulatory evaluation
- Rx to OTC evaluation
- PSURs, PADER, RMP

Requirements

- MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy




- Experience in Medical writing for regulatory submissions in Europe.
- Non-clinicaloverview / Clinical overview / PSUR / EU submission / ClinicalPharmacology / module 2.5 /Scientific Writing ICH / Regulatory Submissions / Medicine / DCP / CTD / Clinical Research / medical writer / Medical Writing / EMA labelling Module 2.4
- Scientific accuracy
- Attention to details
- Understanding of Generic, Hybrid and Recent drug applications
- Experience in Clinical study design and protocol
- Excellent communication skills and time management
- Specialization in Pharmacology desired.

📌 Regulatory Associate - Medical Writing (India)
🏢 Silmed Scientific
📍 India