Job Overview
Acts as Lead Medical Writer on any type of writing project, including projects with multiple deliverables/components. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. 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, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Essential Functions
• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
• Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
• Use experience and initiative to tackle new/unusual document types and customer requirements.
• Chair meetings. Able to act as point of contact for escalations and resolve conflict.
• Participate in bid defense meetings and discussions.
• May design training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team. May propose, plan and deliver general training on Medical Writing to other IQVIA groups and externally, as appropriate.
• May act as Project Manager for a small series of Medical Writing projects, that may involve elements of other functions.
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Independently propose, review and approve budgets and assumptions for a range of project types within remit.
• May take on a partnership lead role.
• Likely to represent region or site on a Medical Writing initiative or cross-functional initiative.
• May draft new Medical Writing Standard Operating Procedures (SOPs) for review and act as reviewer for Medical Writing SOPs, as assigned and appropriate.