Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.