Medical writer

• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies and coordinate across departments
• Lead resolution of client comments
• Complete clinical study protocols, protocol 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
• Follow ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and perform peer reviews
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and resolve issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standards, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Complete administrative tasks and other assigned duties

Explore Senior Medical Writer at Syneos Health. Review requirements and application details.