Job opportunity as Medical Writing Associate at Teva-Apply before 30th May 2024

Teva Pharma

Website Teva

About Teva

Teva is an Israeli pharmaceutical company known for its generic drugs and specialty medicines. It’s one of the largest generic drug manufacturers globally, with a diverse portfolio covering various therapeutic areas such as central nervous system disorders, oncology, respiratory conditions, and more. Teva has a significant presence in the pharmaceutical industry and has been involved in various controversies and legal battles related to patents and pricing practices.

Medical Writing Associate I

Job Description:

  • Coordinate with all concerned departments to ensure timelines and compliance with regulatory/sponsor requirements for the preparation, compilation, and delivery of reports.
  • Prepare study reports for CE/PK studies and Brand studies.
  • Address medical writing-related sponsor queries.
  • Generate amended reports and amendments to the CSR as needed.
  • Electronically generate, review study documents, and submit study reports in CTD/eCTD format according to regulatory requirements.
  • Optionally provide coding for all adverse events recorded in the study using the MedDRA® coding system for clinical trials.
  • Prepare protocols and related documents for BA/BE, clinical endpoint, and phase trials following ICH GCP and applicable regulatory requirements. Conduct literature search and review for the molecule under investigation.
  • Prepare Informed Consent Documents, study-specific documents, and other appendices related to the protocol.

Candidate Profile:

  • 3-5 years of experience in writing reports/technical operations.
  • M.Sc/M.Pharm qualification.

Additional Information:

  • Experience: 3-5 years
  • Qualification: M.Sc/M.Pharm
  • Location: Navi Mumbai
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Functional Area: Medical Writing
  • End Date: 30th May 2024
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