Senior Medical Writer - Clinical Studies & Regulatory Lead

Syneos Health, Inc.; Indiana; Vor Ort; USD 95.000 - 140.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Sr. Medical Writer to support regulatory submissions and scientific communications across drug development. You will lead the creation and editing of clinical study reports, protocols, and related documents, ensuring accuracy and timeliness for Phase II/III programs.

The role requires 3–5 years of medical writing experience, strong knowledge of FDA/ICH guidelines, and ability to mentor junior writers while coordinating with cross-functional teams and clients.

Qualifikationen

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in biopharmaceutical, device, or contract research organizations.

Aufgaben

• Lead medical writing deliverables for individual studies with minimal supervision.
• Prepare CSRs, IBs, ICFs, protocols and amendments; abstracts and posters as needed.
• Adhere to ICH E3 guidelines and SOPs; ensure on-time, on-budget delivery.
• Coordinate quality reviews and client-comment resolution; mentor junior writers.

Kenntnisse

Medical writing

Regulatory knowledge

Editorial review

Client interaction

Team leadership

Jobbeschreibung

Syneos Health is seeking a Sr. Medical Writer to support regulatory submissions and scientific communications across drug development. You will lead the creation and editing of clinical study reports, protocols, and related documents, ensuring accuracy and timeliness for Phase II/III programs.

The role requires 3–5 years of medical writing experience, strong knowledge of FDA/ICH guidelines, and ability to mentor junior writers while coordinating with cross-functional teams and clients.