Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc). Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.