Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables, including but not limited to Clinical Protocols and amendments, Investigator Brochures, Study Manuals, Case Report Forms, Informed Consent Forms, Clinical Study Reports, Annual Reports, regulatory submissions, abstracts and publications. Interacts with internal and external stakeholders (Key Opinion Leaders, Medical Director, vendors, committees) in support of clinical trial objectives and deliverables, including investigator-sponsored trials.