... . Objectives A member of the global technical CMC team for global regulatory CMC strategy for submissions ... . Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission ...

... . Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts ... clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and ...

... engineering elements of the contract review process as required. Perform cost and technical evaluations ... -functional teams, stakeholders, and external suppliers. The ability to present technical information in a ...