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.
Travel Requirements: International and domestic
Location: US-Based Remote (US Eastern time zone preferred)
RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE
How you’ll spend your day
Write and edit clinical regulatory documents, including submission summaries and other complex documents.
Ensure that 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.
Offer leadership and basic accountability, provide strategic assistance, and planning support for clinical regulatory documents.
Manage contingent workers and/or vendors.
Provide training to others as needed.
