Description

Role & 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 Guides Expert Reports Clinical Expert Reports / Nonclinical Expert Reports / Medical Data Package Annual Report for US NDA Medical write ups, Bio-waiver, responses to RFIs Preparation of medical documents to support R&D departments / Business throughout the drug product life cycle & 505b2 projects: Medical Rationales / Therapeutic justifications Bio-recommendations / Bio-waivers/Bio-reports Any other assigned project / medical write-ups Pre-IND/IND/NDA documents / Initial Paediatric Study Plans / Labels etc. Provide medical support during development / filing phase New product proposals and evaluations Quality standards and trainings Ensure 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.

Role and Responsibilities

• Role & 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 Guides Expert Reports Clinical Expert Reports / Nonclinical Expert Reports / Medical Data Package Annual Report for US NDA Medical write ups, Bio-waiver, responses to RFIs Preparation of medical documents to support R&D departments / Business throughout the drug product life cycle & 505b2 projects: Medical Rationales / Therapeutic justifications Bio-recommendations / Bio-waivers/Bio-reports Any other assigned project / medical write-ups Pre-IND/IND/NDA documents / Initial Paediatric Study Plans / Labels etc. Provide medical support during development / filing phase New product proposals and evaluations Quality standards and trainings Ensure 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.