Medical Writer I

About the role

Syneos Health is looking for a Medical Writer I to work remotely, supporting the Clinical Solutions team. The role compiles, writes, edits and coordinates medical writing deliverables that present scientific information clearly and accurately, working within and across departments with moderate supervision.

Key responsibilities

• Complete documents such as clinical study protocols and amendments, clinical study reports, patient narratives and investigator brochures.
• Follow regulatory standards including ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements and style guides, on time and on budget.
• Coordinate quality and editorial reviews, manage source documentation, lead document reviews and resolve client comments.
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format and consistency.
• Work with clients, department heads and peers to produce writing deliverables.
• Perform online clinical literature searches in line with copyright requirements.
• Identify and propose solutions to document issues, escalating as appropriate, and keep track of project budgets and hours.
• Complete administrative tasks and other assigned duties; minimal travel (less than 25%) may be required.