Expertly prepare (or oversee the work of others), edit, finalize and contribute to the strategic direction of complex clinical and regulatory documents, including clinical trial protocols/amendments, investigator’s brochures, clinical study reports, PIPs, Health Authority briefing packages, Health Authority responses, and clinical CTD submission document. - Proven ability to independently author and critically review key safety and regulatory deliverables, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, signal evaluations, health authority responses, Summaries of Clinical Safety, Clinical Overviews, Integrated Summaries of Safety, CSR safety sections, and patient narratives.