About this role
Role Overview
- Acts as Lead Medical Writer on any type of writing project
- Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs)
- Performs senior review of all types of medical writing deliverables
- Provides feedback and guidance to more junior staff
- Negotiates timelines and discusses/resolves customer comments
- Keeps abreast of current medical and/or technical writing/regulatory knowledge
- Takes a leading role in preparing assigned documents and organizing document reviews
- Plans and organizes workload for assigned projects and tasks
- Uses experience and initiative to tackle new/unusual document types
Requirements
- Bachelor's Degree in life sciences related discipline or related field required
- Master's Degree in life sciences related discipline or related field preferred
- Ph.D. in life sciences related discipline or related field preferred
- At least 3 years of highly relevant experience in regulatory writing
- In-depth knowledge of clinical study reports (CSR), Common Technical Documents (CTD), protocols, and similar documents
- Experience in preparing CTDs and/or tackling new/unusual document types/customer requirements
- Good understanding of common statistical methods used in clinical trials
- Ability to integrate, interpret, and summarize data from various sources
Benefits
- Professional development
- Flexible working hours