Director, Medical Writing

 Summary

The Director, Medical Writing (MW) is responsible for managing MW and quality review (QR) activities

in conjunction with the Head of MW in a timely, accurate, and efficient manner in compliance with company and global regulations, including ICH and GCP. With minimal oversight and self-guided decision-making, the MW Director will work cross-functionally with internal departments and external resources to oversee high-quality, on-time deliverables in support of clinical, non-clinical, and regulatory needs. In addition, the Director supports and mentors less experienced MWs, while providing administrative and project management support to the Head of MW including setting up and amending vendor contracts, setting up group training, communicating pivots or shifts in company objectives, presenting work and status cross-functionally, resolving and de-escalating conflicts and risks. The MW Director will also have individual contributor responsibilities at the document level and may or may not have direct report responsibilities.

Responsibilities

• Ensure appropriate communication on project and program-related matters with the Head of MW.
• Oversee cross-functional communication and deliverables for multiple project and program-related deliverables and initiatives, including creation and maintenance of timelines, as needed.
• Independently prepare and finalize/oversee finalization of Clinical and Regulatory documents with minimal input, including