Medical writer

• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies with minimal supervision
• Coordinate medical writing activities within and 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, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Conduct 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
• Develop expertise in industry topics and regulatory requirements
• Monitor assigned project budgets and communicate status and changes
• Complete required administrative tasks and other assigned duties

Explore Senior Medical Writer – Sponsor-dedicated at Syneos Health. Review requirements and application details.

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