Remote Medical Writer II: Protocols & Amendments Lead

Syneos Health India Private Limited; Canada; Remote; CAD 126,000 - 168,000; Full time

Job summary

Syneos Health is seeking a Sponsor Dedicated Protocol Medical Writer II for a remote-based role across Canada, the US, the UK, and Serbia. The candidate will lead protocol writing and amendments, coordinate with Clinical Scientists, and manage multiple medical writing deliverables across studies.

The position requires 3–5 years of medical writing experience, with exposure to protocol writing and familiarity with FDA/ICH guidelines.

Qualifications

• 3-5 years of medical writing experience with protocol writing experience.
• Experience with late development.
• Experience with Oncology/Hematology/Cell therapy.
• Strong understanding of FDA/ICH regulations and good publication practices.

Responsibilities

• Lead medical writing deliverables for protocols, amendments, and reports.
• Coordinate with cross-functional teams and manage client comments.
• Ensure regulatory standards and templates are followed in all documents.
• Mentor less experienced writers on complex projects.

Skills

Medical writing

Protocol writing

Late development

Oncology/Hematology/Cell therapy

FDA/ICH regulations

Publication practices

Job description

Syneos Health is seeking a Sponsor Dedicated Protocol Medical Writer II for a remote-based role across Canada, the US, the UK, and Serbia. The candidate will lead protocol writing and amendments, coordinate with Clinical Scientists, and manage multiple medical writing deliverables across studies.

The position requires 3–5 years of medical writing experience, with exposure to protocol writing and familiarity with FDA/ICH guidelines.