• Develop regulatory documents for submission to regulatory agencies globally • Manage medical writing projects, including developing timelines and communication with cross-functional team members • Participate in cross-functional meetings to provide input regarding medical writing deliverables • Review other documents associated with the assigned project(s) • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects • Mentor more junior medical writing staff