Description
We are seeking a Lead Medical Writer to join our team in Shanghai, China or Beijing, China. As a Lead Medical Writer, you will play a key role in preparing complex clinical study reports, protocols, and other documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements.
Responsibilities:
- Take a leading role in preparing assigned documents, including confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, and communicating directly with the customer.
- Manage day-to-day workload, identifying project needs, tracking timelines, and implementing customer requests.
- Lead customer meetings independently and provide presentations to existing customers.
- Deliver basic level training to small groups or individuals within IQVIA on the role of the medical writer, medical writing processes, or specific customer templates/processes.
- May take on the role of Project Manager for a small and short Medical Writing project.
- Complete project finance activities, including monitoring and forecasting budgeted hours.
- Understand budgets and project finance principles.
Requirements:
- Bachelor's Degree in life sciences related discipline or related field.
- Typically requires at least 3 years of prior relevant experience and related competency levels.
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
- Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
- In-depth knowledge of drug development, medical writing, and associated regulations.
- Excellent written and oral communication skills, including grammatical/technical writing skills.
- Excellent attention to detail and accuracy.
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
Benefits: No specific benefits mentioned.