Principal Medical Writer (Sponsor-Dedicated)

About the role

Syneos Health is hiring a Principal Medical Writer (Sr Principal Medical Writer) in a sponsor-dedicated capacity, working remotely. The role leads the completion of complex medical writing deliverables, defines document strategy for individual studies and coordinates writing activities across departments with minimal supervision.

Key responsibilities

• Lead the clear and accurate completion of complex medical writing deliverables and manage writing activities for individual studies, resolving client comments
• Write documents such as clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PUSRs, clinical development plans, IND submissions, NDA and eCTD submissions, manuscripts and abstracts
• Adhere to regulatory standards (e.g., ICH E3), SOPs, templates, authorship requirements and style guides, on time and on budget
• Advise clients and study teams on data presentation and production strategies, and lead document reviews and quality and editorial reviews
• Act as peer reviewer, review statistical analysis plans and table/figure specifications, and build working relationships with clients and colleagues in data management, biostatistics, regulatory affairs and medical affairs
• Perform online clinical literature searches, propose solutions to issues, mentor junior writers and contribute to internal materials and process improvements
• Manage project budgets and timelines, negotiate deliverables, represent the department on study teams and at conferences, and complete administrative tasks

Required profile

• At least 6 years of relevant experience in science, technical or medical writing
• Extensive experience in the biopharmaceutical, device or contract research organization industry
• Advanced understanding of FDA and ICH regulations and guidelines, and of good publication practices
• Strong English grammar and communication skills, with strong familiarity with the AMA Manual of Style