Sr Medical Writer - Sponsor-dedicated

Responsibilities

• Lead medical writing deliverables, ensuring scientific information is clear and accurate

• Manage medical writing activities for individual studies with minimal supervision

• Lead resolution of client comments

• Author protocols, clinical study reports, patient narratives, IBs, IND/NDA submissions, and manuscripts

• Adhere to ICH E3, SOPs, client standards and templates

• Coordinate quality and editorial reviews and peer review internal documents

• Review statistical analysis plans and TLF specifications

• Mentor less experienced medical writers

Requirements

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

• Experience in biopharmaceutical, device or CRO industry

• Strong understanding of FDA and ICH regulations

• Experience writing relevant regulatory document types

• Extensive English grammar knowledge and AMA Manual of Style familiarity

About the Company

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