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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]

2 reviews

Kuldeep Singh Sandhu November 8, 2022 at 7:40 pm
Reeta yadav November 8, 2022 at 9:00 pm

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