Principal Medical Writer

About the role

Principal Medical Writer at Syneos Health, a leading fully-integrated life sciences services organization. You will lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. This role involves managing medical writing activities for individual studies, defining document strategy, and coordinating activities within and across departments with minimal supervision.

Responsibilities

• Leads the completion of complex medical writing deliverables, ensuring clarity and accuracy of scientific information.
• Manages medical writing activities for individual studies, including defining document strategy and coordinating activities within and across departments.
• Leads the resolution of client comments.
• Authors a variety of documents, including but not limited to:
  • Clinical study protocols and amendments
  • Clinical study reports
  • Patient narratives
  • Annual reports
  • Investigator brochures
  • Informed consents
  • Plain language summaries
  • Periodic safety update reports
  • Clinical development plans
  • IND submissions
  • Integrated summary reports
  • NDA and eCTD submissions
  • Journal manuscripts
  • Abstracts, posters, and presentations for scientific meetings
• Adheres to established regulatory standards (e.g., ICH E3 guidelines), company SOPs, client standards, and approved templates.
• Advises clients and study teams on data presentation and production strategies to meet objectives and maintain quality standards.
• Leads team document reviews and ensures technical accuracy; coordinates quality and editorial reviews.
• Serves as an expert peer reviewer for internal teams, ensuring clarity, accuracy, and relevance of documents.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Interacts and builds relationships with clients, department heads, and cross-functional teams (e.g., data management, biostatistics, regulatory affairs).
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to issues, escalating as appropriate.
• Serves as a key technical subject matter expert (SME) and contributes to internal materials and process improvements.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on industry topics and regulatory requirements; engages with industry groups on initiatives.
• Monitors budget specifications for assigned projects and communicates status to leadership.
• Contributes to bid projections and negotiates timelines for deliverables.
• Represents the medical writing department on clinical study teams, at conferences, and in client presentations.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

Principal Medical Writer on clinical study or regulatory project teams. Provides scientific writing, regulatory guidance, and technical expertise in the writing, production, and review of high-quality complex regulatory and other scientific/clinical documents. Ensures clinical data is presented in compliance with applicable regulatory guidelines.