Medical Writing Manager - EMEA/USA

The ICON Medical Writing Manager will:

• Supervise Medical Writers and provide general assistance to the medical writing team.
• Organize and maintain the medical writing work schedule.
• Assign suitably experienced Medical Writers to projects.
• Conduct performance reviews and discussions with line reports.
• Liaise with sponsors, Clinical Project Managers, and new business personnel with regard to the availability of medical writing resources and the establishment of project timelines.
• Obtain project progress reports from the Senior Medical Writers and use this information to ensure the maintenance of document quality and project timelines.
• Write, perform internal reviews, and QC regulatory documents (eg, CSRs, protocols, IBs, periodic safety reports, INDs, eCTD/NDA clinical summaries) prepared by the medical writing team.
• Liaise with the cross-functional team to ensure the maintenance of document quality and project timelines.
• Inform the medical writing senior management team, when required, of the status of projects and, in particular, any issues that affect document quality and project budget.
• Provide new business cost estimates when required, and support Business Development in new business acquisitions for medical writing projects.
• Manage the administrative requirements of the medical writing department.
• Provide ongoing training/mentoring to the medical writing team.

Experience:

• BS in a scientific or medical discipline with relevant writing experience is required. Advanced degree (MS/PhD) is preferred.

• Experience as a Medical Writer in a CRO and/or pharmaceutical/biotechnology setting.
• Experience as a Line Manager is preferred.

Other Experience:

• In-depth understanding of regulatory/ICH guidelines and GCPs.
• Demonstrated ability to work effectively and efficiently in a fast-paced environment.
• Impeccable attention to detail and strong problem-solving skills.
• Excellent communication skills.