Lead Medical Writer - Sponsor-Dedicated

Syneos Health, Inc.; Polska; On-site; PLN 180,000 - 340,000; Full time

Job summary

Syneos Health seeks a Principal Medical Writer to lead sponsor-dedicated medical writing efforts, ensuring accurate presentation of complex regulatory content across protocols, reports, manuals, and manuscripts.

The role includes mentoring junior writers, coordinating with data management, biostatistics, regulatory, and medical affairs, and delivering high-quality documents that meet client objectives on time.

Qualifications

• At least 6 years of relevant experience in science, technical, or medical writing.
• Extensive experience working in the biopharmaceutical, device, or contract research organization industry.
• Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices.
• Extensive experience writing relevant document types.
• Extensive knowledge of English grammar and able to communicate clearly; strong familiarity with AMA Manual of Style.

Responsibilities

• Leads the clear and accurate completion of complex medical writing deliverables.
• Manages medical writing activities associated with individual studies, coordinating across departments.
• Advises clients and study teams on data presentation and production strategies.
• Leads team document reviews and coordinates quality and editorial reviews.
• Serves as expert peer reviewer and mentors less experienced writers.
• Reviews statistical analysis plans and ensures consistency and clarity.
• Interacts with clients and study teams to meet objectives and delivery timelines.
• Performs online literature searches and ensures copyright compliance.

Skills

Medical writing

Regulatory writing

Biopharma industry

FDA/ICH knowledge

English grammar

AMA style

Job description

Syneos Health seeks a Principal Medical Writer to lead sponsor-dedicated medical writing efforts, ensuring accurate presentation of complex regulatory content across protocols, reports, manuals, and manuscripts.

The role includes mentoring junior writers, coordinating with data management, biostatistics, regulatory, and medical affairs, and delivering high-quality documents that meet client objectives on time.