Description
We are seeking a Lead Medical Writer to join our team. As a Lead Medical Writer, you will play a key role in preparing assigned documents, including complex clinical study reports, protocols, and other challenging indications or customer-specific documents. You will be responsible for ensuring that all documents are prepared in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements, and that they meet the agreed timelines.
Key responsibilities include:
- Taking 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
- Managing day-to-day workload, identifying project needs, tracking timelines, and implementing customer requests
- Leading customer meetings independently and delivering basic level training to small groups or individuals within IQVIA
- Providing guidance to more junior colleagues and proposing revisions to standard operating procedures (SOPs) or suggesting process improvements for consideration
- Completing project finance activities, including monitoring and forecasting budgeted hours
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
- Excellent written and oral communication skills, including grammatical/technical writing skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers