Sr Medical Writer - Sponsor-dedicated (UK, Poland, Spain, Serbia)
- Writing types
- Regulatory, Publications, Editing
- Seniority
- Senior
About the role
Responsibilities
- Lead clear, accurate medical writing deliverables for individual studies
- Author protocols, clinical study reports, narratives, IND/NDA submissions and manuscripts
- Coordinate quality and editorial reviews and resolve client comments
- Peer review documents and statistical analysis plan specifications
- Mentor less experienced medical writers on complex projects
- Manage budgets and report status to medical writing leadership
Requirements
- 3-5 years in science, technical or medical writing
- Experience in biopharmaceutical, device or CRO industry
- Strong understanding of FDA and ICH regulations and publication practices
- Experience writing relevant regulatory document types
- Extensive English grammar knowledge and familiarity with AMA Manual of Style
About the Company
Syneos Health is a fully-integrated life sciences services organization partnering with innovators across drug development and commercialization.
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