Medical Writing Manager (ICON Medical Imaging) JR066540
• Supervises and provides general assistance to the Imaging Medical Writing Team.
• Organizes and maintains the medical writing work schedule.
• Assigns suitably experienced Medical Writers to projects.
• Liaises with Clinical Project Managers with regard to the availability of medical
writing resources and the establishment of project timelines.
• Writes and reviews documents prepared by the Medical Writers including studyspecific documents such as Independent Review Charters (IRC),
Site Imaging Manuals (SIM) and Independent Review Training Manuals (IRTM).
• Understands key reading criteria such as RECIST, mRECIST, Choi, RANO, Cheson,
Lugano Classification, Halleck, iRECIST, RECIL, iRANO/bmRANO/pedRANO,
PCWG, and PCWG3.
• Knowledge of current industry regulations and standards.
• Keeps the medical writing senior management informed, when required, of the status
of medical writing projects and, in particular, any issues that affect document quality.
• Collaborates with imaging department heads and project teams to prioritize
deliverables and support project scope of work.
• Manages the administrative requirements of the department.
• Prepares monthly metrics reports and presents to senior management.
• Provides input to Standard Operating Procedures and Work Instruction documents as
• Ensures correct conduct of ongoing projects and effective representation of the
department's capabilities for potential projects.
• Ensures that sponsor projects are implemented and conducted in accordance with
• Assesses and maintains the quality of department deliverables.
• Provides new business cost estimates when required and supports Business
Development in new business acquisitions for medical writing projects.
• Bachelor's or Master’s degree in Life Sciences/Health Related Sciences or equivalent
• Medical/technical writing experience of 7+ years in a clinical research setting.
• Experience in a managerial or lead role, including project/resource allocation
experience. People management experience is preferred.
• Demonstrated understanding of clinical research, the drug development process, and
applicable regulatory guidelines.
• Able to work independently.
• Attention to detail and ability to multitask.