Senior Medical Writer - Europe (Home Based)

About the role

Syneos Health is hiring a Senior Medical Writer for its FSP Team, a full-time permanent position. Candidates can be considered from anywhere in EMEA except Switzerland, Germany and France, working remotely from home. The role covers the complete range of medical writing deliverables, from clinical study protocols to regulatory submissions, with coordination of reviews and mentoring of junior writers.

Key responsibilities

• Complete medical writing deliverables accurately and on time and on budget, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PUSRs, clinical development plans, IND submissions, NDA and eCTD submissions, journal manuscripts and meeting materials.
• Manage writing activities for individual studies, coordinate them across departments with minimal supervision, and lead the resolution of client comments.
• Follow regulatory standards such as ICH E3, company SOPs, client standards and approved templates, and coordinate quality and editorial reviews.
• Review statistical analysis plans and table/figure specifications, and act as peer reviewer for the internal team.
• Work with clients, department heads and colleagues in data management, biostatistics, regulatory affairs and medical affairs, and search clinical literature while respecting copyright.
• Mentor less experienced writers, provide training and technical support, and escalate issues as appropriate.
• Stay aware of project budgets and complete administrative tasks within set timeframes.

Required profile

• 3-5 years of relevant experience in science, technical or medical writing.
• Experience in the biopharmaceutical, device or CRO industry is required.
• FSP or CRO experience preferred.
• Strong understanding of FDA and ICH regulations and good publication practices strongly required.
• Extensive knowledge of English grammar and strong familiarity with the AMA Manual of Style.

Required skills

• Veeva Vault (mandatory)
• Tech savvy and comfort using technology
• Writing of the document types listed above