Regulatory Associate - Medical Writing Silmed Scientific

3.0 - 7.0 years

0 Lacs

kochi, kerala

On-site

As an experienced medical writer with expertise in CTD medical writing and clinical development of medicines, your responsibilities will include the following: Writing high-quality CTD modules such as nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) to meet EU submission requirements. Addressing clinical deficiencies by providing appropriate responses. Contributing to drug development strategy. Updating documents like SmPC, Patient Information Leaflet, CCDS, Safety variations. Preparing Clinical Study Reports, Study design, and synopsis. Assisting in the formulation of clinical development strategies and reviewing study reports and published papers. Conducting literature searches and regulatory evaluations. Evaluating Rx to OTC transitions. Handling tasks such as PSURs, PADER, and RMP. To be considered for this role, you should have the following qualifications and skills: MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy. Prior experience in medical writing for regulatory submissions in Europe. Expertise in areas like non-clinical overview, clinical overview, PSUR, EU submission, Clinical Pharmacology, module 2.5, Scientific Writing ICH, Regulatory Submissions, Medicine, DCP, CTD, Clinical Research, medical writer, Medical Writing, and EMA labelling Module 2.4. Demonstrated scientific accuracy and attention to detail. Understanding of Generic, Hybrid, and New drug applications. Proficiency in Clinical study design and protocol development. Excellent communication abilities and efficient time management. Specialization in Pharmacology would be advantageous for this role.,

Posted 1 week ago

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