Senior Medical Writer - Europe/home based - FSP Team

Responsibilities

• Lead completion of medical writing deliverables for clinical and regulatory documents

• Manage medical writing activities for individual studies with minimal supervision

• Lead resolution of client comments and coordinate quality and editorial reviews

• Review statistical analysis plans and table, figure and listing specifications

• Mentor less experienced medical writers on complex projects

• Work with clients and peers in data management, biostatistics, regulatory and medical affairs

Requirements

• 3-5 years of relevant experience in science, technical or medical writing

• Experience in biopharmaceutical, device or CRO industry

• Strong understanding of FDA and ICH regulations and good publication practices

• Experience writing protocols, clinical study reports and other relevant document types

• Extensive knowledge of English grammar and familiarity with AMA Manual of Style

• Comfortable using technology, Veeva Vault required

Preferred Qualifications

• FSP or CRO experience

About the Company

Syneos Health is a fully-integrated life sciences services organization partnering with innovators across drug development and commercialization.