Participation in reviewing the clinical sections of regulatory submission dossiers, documents for scientific consultations (e.g., Scientific Advice, PIP, benefit dossier, etc.), or orphan drug applications in consultation with the Head of Clinical Research * Participation in coordinating and drafting responses to clinical deficiency letters in regulatory procedures in consultation with the Head of Clinical Research * Review and approval of critical development documents (e.g., Clinical Trial Protocol, master ICF, Statistical Analysis Plan, Clinical Trial Protocol) * Review and negotiation of study budgets with service providers (e.g., CRO, central laboratory) * Review and approval of and contracts (e.g., CRO, central laboratory) * Preparation of cross-functional presentations for senior management (e.g., deep dives, global program updates, phase transitions)
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