Medical Writer

Sciformix - Pune, Maharashtra (4 months ago)

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Responsibilities
  • Write various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
  • Write Investigator brochures and sections of protocols
  • Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
  • Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process
  • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
  • Ensure compliance of operations with governing regulatory requirements
Skills
  • Master’s degree in Pharmacy/related science area with at least 2 years of experience in the pharmaceutical industry
  • Strong working knowledge of anatomy, physiology, disease states, medical treatments and procedures, medication names and drug therapy
  • Thorough understanding of drug safety
  • Orientation to pharmacokinetic and pharmacodynamic principles
  • Strong written and verbal language skills
  • Ability to analyze and synthesize medical information
  • Basic understanding of statistical concepts
  • Concern for quality, detail orientation