Medical Writer

1 month ago


Gurgaon, India SUN PHARMA Full time
Job Responsibilities:

Preparation of medical writing documents for fresh and renewal filing within the defined timelines. Medical Writing Documents include:Labels – Prescribing information/Summary of Product Characteristics / Patient Information Leaflet / Medication GuidesExpert Reports – Clinical Expert Reports / Nonclinical Expert Reports / Medical Data PackageAnnual Report for US NDAMedical write ups, Bio-waiver, responses to RFIsPreparation of medical documents to support R&D departments / Business throughout the drug product life cycle & 505b2 projects:Medical Rationales / Therapeutic justificationsBio-recommendations / Bio-waivers/Bio-reportsAny other assigned project / medical write-upsPre-IND/IND/NDA documents / Initial Paediatric Study Plans / Labels etc.Provide medical support during development / filing phaseNew product proposals and evaluationsQuality standards and trainingsEnsure compliance to SOPs and regulatory guidelines and zero critical errors in documents as per quality metrics (QM).To attend and conduct assigned training sessions for the team.



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