Medical writer

• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities associated with individual studies and coordinate activities 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
• Adhere to 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 peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Build working relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions, escalating issues as appropriate
• Provide technical support, training, and consultation
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Monitor budgeted hours and communicate status and changes to medical writing leadership
• Complete administrative tasks and other assigned duties

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

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