Medical Writter

**Title**:Medical Writter**:

- Date: Dec 5, 2024- Location: Gurgaon - R&D- Company: Sun Pharmaceutical Industries Ltd**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.