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The opportunity
A Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.
How you’ll spend your day
Primarily works at project level
May oversee contingent workers and/ or vendors; may provide training to others as needed
Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents
Writers and edits clinical regulatory documents, including submission summaries and other complex documents
Ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
May participate in the preparation/revision of document templates