ICON Clinical Research
*The ICON Medical Writing Manager will:*If you need to know concerning the necessities for this position, learn on for all of the related info.* Supervise Medical Writers and supply basic help to the medical writing group.* Organize and keep the medical writing work schedule.* Assign suitably skilled Medical Writers to initiatives.* Conduct efficiency evaluations and discussions with line studies.* Liaise with sponsors, Clinical Project Managers, and new enterprise personnel with regard to the supply of medical writing assets and the institution of mission timelines.* Obtain mission progress studies from the Senior Medical Writers and use this info to make sure the upkeep of doc high quality and mission timelines.* Write, carry out inner evaluations, and QC regulatory paperwork (eg, CSRs, protocols, IBs, periodic security studies, INDs, eCTD/NDA medical summaries) ready by the medical writing group.* Liaise with the cross-functional group to make sure the upkeep of doc high quality and mission timelines.* Inform the medical writing senior administration group, when required, of the standing of initiatives and, specifically, any points that have an effect on doc high quality and mission funds.* Provide new enterprise price estimates when required, and help Business Development in new enterprise acquisitions for medical writing initiatives.* Manage the executive necessities of the medical writing division.* Provide ongoing coaching/mentoring to the medical writing group.Experience:* BS in a scientific or medical self-discipline with related writing expertise is required. Advanced diploma (MS/PhD) is most well-liked.* Experience as a Medical Writer in a CRO and/or pharmaceutical/biotechnology setting.* Experience as a Line Manager is most well-liked.Other Experience:* In-depth understanding of regulatory/ICH pointers and GCPs.* Demonstrated potential to work successfully and effectively in a fast-paced surroundings.* Impeccable consideration to element and robust problem-solving abilities.* Excellent communication abilities.