Lead Medical Writer - Late Phase Clinical Projects

About the role

IQVIA is looking for a Lead Medical Writer based in Seoul to act as lead writer on late phase clinical projects, including PMS and NIS. Documents are prepared according to IQVIA SOPs and customer requirements within agreed timelines, with negotiation of timelines and resolution of customer comments supported by senior staff.

Key responsibilities

• Prepare assigned documents, confirm scope, templates and specifications, negotiate and adhere to timelines, organize document reviews and communicate directly with the customer
• Manage day-to-day workload: identify project needs, track timelines, implement customer requests and keep managers and senior staff informed of progress and issues
• Attend project team meetings and take part in or lead comments-resolution meetings with external customers
• May give a simple presentation to an existing customer, for example on medical writing processes at a project kick-off
• Complete project finance activities, including monitoring and forecasting budgeted hours, and build awareness of budgets and out-of-scope activities

Required profile

• Bachelor's degree in a life sciences-related discipline or related field; master's or Ph.D. preferred
• 1.5+ years of prior relevant experience
• Familiarity with the structure and content of clinical study reports, protocols and similar documents
• Good understanding of common statistical methods used in clinical trials and ability to review statistical analysis plans and spot errors in statistical output
• In-depth knowledge of drug development, medical writing and associated regulations, and good understanding of statistical principles and medical terminology across therapeutic areas
• Excellent written and oral communication, attention to detail, accuracy, collaboration, and ability to manage multiple tasks and projects
• Computer literate