The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion. […]
Opportunities to write or contribute to other Regulatory documents may be provided Represents MW at meetings Drives document development meetings Articulates document strategy and timelines Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss Follows discussions to...