This role leads the preparation and review of clinical trial and regulatory documents as a senior/lead medical writer. It manages project deliverables, client interactions, timelines, quality, scope, and profitability, while supervising and developing team members and maintaining high engagement. The position also collaborates with sales on proposals and builds strong cross-departmental relationships. Candidates should have a life-science degree, at least eight years of medical writing experience with three years of line management, deep knowledge of protocols, clinical study reports and CTDs, the ability to review statistical plans and outputs, integrate and interpret data from multiple sources, and strong leadership, project management, business, and financial skills.
Requirements
Experienced medical writing leader with a life-science degree, over eight years of medical writing and at least three years of line management. Possesses deep expertise in clinical trial documentation, reviewing statistical analysis plans, and integrating data from multiple sources. Brings strong leadership, project management, and multitasking skills, along with sound judgment, negotiation, business acumen, and financial/budget planning capability.