ICON Clinical Research

Medical Writing Manager

Location
Lombardy
Salary
Competitive
Posted
27 Jul 2021
Closes
25 Aug 2021
Ref
JR077308
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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.

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