Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
May assist in program management activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables.
Represents the department at project launch meetings, review meetings, and project team meetings.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred....