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Job highlights

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Time management

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Position: Executive – Biopharmaceutics (Clinical Research)
Location: R&D Centre, Gandhinagar, Gujarat
Department: Biopharmaceutics (Clinical Research)

Qualifications:

  • Degree: M.Pharm (Pharmacology)
  • Experience: 2 to 5 years in Clinical Research

Key Responsibilities:

  • Conduct feasibility assessments and evaluate new products.
  • Perform literature reviews and design BA/BE (Bioavailability/Bioequivalence) studies.
  • Monitor Bioequivalence (BE) studies.
  • Prepare documents for regulatory submissions (e.g., BENOC, Import License applications).
  • Establish and maintain study documentation.
  • Prepare dossier submission documents (including Clinical Overview, Non-Clinical Overview, and Summary Tables).
  • Review BE study documents such as protocols, reports, Informed Consent Forms (ICF), etc.
  • Prepare and review medical and scientific write-ups.
  • Coordinate the reporting of serious adverse events (SAEs) and provide safety updates to regulatory agencies.

Interested candidates may send their resumes to: