Associate Director, Medical Writing
: Job Details :

The Associate Director, Medical Writing is responsible for the complete preparation, including but not limited to, the writing, reviewing, and editing of Protocols, Investigator Brochures (I - Bs), Clinical Study Reports (CSRs), and Clinical Summary Modules for regulatory submissions. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines, and basic knowledge of document management systems. They will be responsible for leading all medical writing activities of one or more clinical development program(s). Responsibilities (Essential Role Responsibilities):Acts as the lead medical writer and responsible for the complete preparation of all documents for assigned clinical development programs. Performs hands-on authoring of critical documents. Provides leadership/document strategy at the program level. Plan and negotiate timelines. Critically reviews documents produced by internal and external writers for scientific content and alig...Director, Medical, Associate, Clinical, Technology, Healthcare, Development