Medical Writer

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.