Navita’s Life Sciences Hiring Lead Medical Writer

Navita’s Life Sciences Hiring Lead Medical Writer

11 May, 2022

Roles and Responsibilities

  • Developing Clinical Study Outlines
  • Designing protocols for clinical trials Phase I to IV and for bioavailability /bioequivalence studies
  • Preparation of Clinical Study Reports for Phase I to IV clinical trials and Bioavailability/ Bioequivalence studies for submission to regulatory authorities
  • Preparation of Common Technical documents (CTD) for Regulatory Authority submission
  • Preparation of Manuscript ICF, PIS, IBs and PSUR
  • Protocol briefing sessions of clinical operations, statisticians & data management team
  • SAE Narrative preparation
  • Departmental SOP preparation and revision
  • Support to Business Development in preparation of clinical trial proposals
  • Feasibility analysis for the clinical trials by discussing with specialists in various therapeutic areas
  • Preparing Feasibility questionnaires to support Clinical Operations

Desired Candidate Profile

  • Exp: 5-8 yrs.
  • Preferred experience in eCTD authoring, protocol, IB, CSR reports, Clinical trials (phase I, II, III, IV)

Apply through this Link

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