posted 3 april 2025reference number JPC - 106691next stepsjob detailsRequired Attributes : Minimum 10 years of experience with excellent communication skill.
Experience in Innovator/reference drugs vs Generic drugs (Innovator drug experience is mandate)
Experience in Clinical Study Reports; nonclinical reports authoring is a plus - evaluate with respect to Innovator/reference drugs vs Generic drugs);
Experience in Protocol - new vs amendment - evaluate with respect to Innovator/reference drugs vs Generic drugs)
Experience in Investigator's Brochure (IB) - new (de novo) or update - evaluate with respect to Innovator/reference drugs vs Generic drugs);
Experience in CTD modules - 2.5. (clinical overview) and 2.7 (clinical summaries)
Experience in Briefing Books - evaluate with respect to Innovator/reference drugs vs Generic drugs)