• Prepare, review, and challenge key development and regulatory documents, including protocols, study reports, investigator brochures, briefing packages, IND/CTA/IMPD documents, CTD sections, authority responses, and scientific position papers. • 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. • Strong scientific writing, communication, and stakeholder-management skills, with the ability to explain complex clinical pharmacology and DMPK topics clearly to cross-functional teams and senior decision-makers.
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