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 leads the clear and accurate completion of medical writing deliverables, with minimal supervision.

Key responsibilities

• Manage medical writing activities for individual studies, coordinate across departments and lead the resolution of client comments
• Write clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PUSRs, clinical development plans, IND submissions, NDA/eCTD submissions, manuscripts, abstracts, posters and presentations
• Follow regulatory standards such as ICH E3, company SOPs, client standards and templates, and complete projects on time and within budget
• Coordinate quality and editorial reviews, manage source documentation, review documents and act as peer reviewer
• Review statistical analysis plans and table/figure specifications, and provide feedback
• Work with clients and colleagues in data management, biostatistics, regulatory affairs and medical affairs, and perform online literature searches while respecting copyright
• Mentor less experienced writers, provide training and technical support, and mentor on complex projects
• Track project budgets, handle administrative tasks and accept other assigned duties; minimal travel (less than 25%)

Required profile

• 3-5 years of relevant experience in science, technical or medical writing
• Experience in the biopharmaceutical, device or CRO industry 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
• Experience writing the document types listed above