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 Current drug applications
Experience in Clinical study design and protocol
Excellent communication skills and time management
Specialization in Pharmacology desired.