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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. .