A Senior Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides intermediate-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.

Essential Duties & Responsibilities:

1.Primarily works on the product/program level

2.Possible to have direct reports; likely to oversee contingent workers and/or vendors; likely to provide training to others; and analyzes needs to manage resources

3.Offers leadership and fundamental accountability, provides strategic supervision, and planning assistance for clinical regulatory documents

4.Writes and edits clinical regulatory documents (all types).

5.Ensures 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

6.Participates in the preparation/revision of document templates