Found Description
The Role & What You Will Be Doing
The Expert Medical Writer provides strategic, scientific, and operational leadership for the planning, authoring, and coordination of high-impact clinical and regulatory documents that support global marketing applications. In addition to hands‑on writing, the role serves as Programme Medical Writer for complex submissions, drives documentation strategy across therapeutic areas, mentors a team of writers, and champions continuous improvement of writing processes with a specific focus on new technologies.
Responsibilities
- Program‑level leadership – Lead, oversee, and coordinate medical‑writing deliverables for full CTD submissions across multiple development programs (e.g., clinical‑overview and summary modules) ensuring scientific integrity, consistency, and on‑time delivery.
- Scientific & strategic contribution – Act as subject‑matter expert on regulatory requirements; provide guidance on data‑poo...