Remote Principal Medical Writer – Publications

Syneos Health, Inc.; Ontario (CA); Sur place; USD 78 000 - 120 000; Plein temps

Résumé du poste

Syneos Health is seeking a Principal Medical Writer to lead complex medical writing projects for clinical studies and regulatory submissions. The role emphasizes delivering high-quality documents, guiding editorial standards, and providing strategic input on data presentation for clients worldwide.

You will interact with data management, biostatistics, regulatory, and medical affairs teams while mentoring junior writers. Travel is less than 25%.

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 required.
• Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices required.
• Extensive knowledge of English grammar and able to communicate clearly; strong familiarity with AMA Manual of Style.

Responsabilités

• Leads the clear and accurate completion of complex medical writing deliverables and coordinates activities with minimal supervision.
• Produces a wide range of documents including study protocols, reports, narratives, informed consents, and journal manuscripts.
• Ensures regulatory standards and templates are followed, and maintains quality and on-time delivery.
• Mentors less experienced writers and serves as SME for internal and client-facing projects.

Connaissances

Medical writing

FDA/ICH regulations

AMA Style familiarity

Description du poste

Syneos Health is seeking a Principal Medical Writer to lead complex medical writing projects for clinical studies and regulatory submissions. The role emphasizes delivering high-quality documents, guiding editorial standards, and providing strategic input on data presentation for clients worldwide.

You will interact with data management, biostatistics, regulatory, and medical affairs teams while mentoring junior writers. Travel is less than 25%.