At the same time, the person must understand the mindset and expectations of regulatory authorities and be able to prepare persuasive, scientifically sound documentation, briefing materials, position papers, and responses to authority questions. • Demonstrated experience preparing, reviewing, and defending regulatory and development documentation, including protocols, study reports, investigator brochures, briefing packages, IND/CTA/IMPD documents, CTD sections, responses to authority questions, and scientific position papers.
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