- 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)
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