Senior Medical Writer (Clinical Documentation Lead)

Syneos Health/ inVentiv Health Commercial LLC; Kansas City (MO); On-site; USD 81,000 - 176,000; Full time

Job summary

Syneos Health is seeking a Senior Medical Writer (FSP) with clinical document writing experience across protocols, CSRs and IBs to lead high-quality regulatory submissions. You will manage writing deliverables, coordinate across departments, and mentor junior writers while ensuring compliance with ICH E3 and internal templates.

In this role you will interact with clients and cross-functional teams, oversee timelines and budgets, and contribute to development of internal processes.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, coordinating activities with minimal supervision.
• Adheres to regulatory standards including ICH E3 and approved templates and style guides.
• Coordinates quality and editorial reviews and ensures source documentation is managed properly.
• Mentors and leads less experienced medical writers on complex projects.

Job description

Syneos Health is seeking a Senior Medical Writer (FSP) with clinical document writing experience across protocols, CSRs and IBs to lead high-quality regulatory submissions. You will manage writing deliverables, coordinate across departments, and mentor junior writers while ensuring compliance with ICH E3 and internal templates.

In this role you will interact with clients and cross-functional teams, oversee timelines and budgets, and contribute to development of internal processes.