Senior Medical Writer (CSR, Protocols, IB and Regulatory Documents)

About the role

Syneos Health is hiring a Senior Medical Writer for a Sponsor Dedicated position, working remotely. The role leads the clear and accurate completion of medical writing deliverables, manages writing activities for individual studies with minimal supervision, and coordinates quality and editorial reviews.

Key responsibilities

• Lead the resolution of client comments and coordinate quality and editorial reviews
• Write clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PUSRs, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts and meeting abstracts, posters and presentations
• Follow ICH E3 guidelines, company SOPs, client standards and approved templates, and stay within budgeted hours
• Review statistical analysis plans and table/figure specifications, and act as peer reviewer for the team
• Perform online clinical literature searches in line with copyright requirements
• Mentor less experienced writers, provide technical support and training, and handle administrative tasks

Required profile

• 3-5 years of relevant experience in regulatory writing
• Experience in the biopharmaceutical, device or contract research organization industry
• Extensive knowledge of English grammar and clear communication
• Strong familiarity with the AMA Manual of Style
• Minimal travel (less than 25%) may be required

Required skills

• Strong understanding of EMA, FDA and ICH regulations and good publication practices
• Experience writing the document types listed above