Sun Pharma Medical Writer Job Openings – Gurgaon
Sun Pharma is Hiring Medical Writer – Gurgaon
location : Gurgaon Office Based
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/INDINDA documents/Initial Paediatric
- Study Plans/Lubels etc.
- Provide medical support during development / filing phase
- New product proposals and evaluations
Preparation and review of Health Hazard Evaluation (HHE)/any other safety evaluation as per organization requirement
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 tear.
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/INDINDA documents/Initial Paediatric Study Plans / Labels etc. Provide medical support during development / filing phase
- New product proposals and evaluations
- Preparation and review of Health Hazard Evaluation (HHE)/any other safety evaluation as per organization requirement
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.
Experience : 02 to 05 years
Application Process
Interested candidate can share their resume on [email protected]
