Medical Writer

1 week ago


Gurugram, 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 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.


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