ICON Clinical Research

Medical Writing Manager

Location
London
Salary
Competitive
Posted
14 May 2021
Closes
13 Jun 2021
Ref
JR066540
Discipline
Clinical Research
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.

#LI-GSO1

Similar jobs

Similar jobs