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    Senior director of project management - Bristol, United Kingdom - ClickJobs

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    Description

    Role:
    Senior Director,

    Regulatory Medical Writing Location:

    Europe Travel:

    Homebased Position Summary:
    Contributes to and champions internal standards, regulatory, and publishing guidelines. Able to oversee the work of external contractors. Manage a team of internal medical writers (direct reports). Mead lead in resource management and actively participate in hiring decisions.

    Prepares and finalizes all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy.

    Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.

    Works with a high-level of independence and takes a lead role on assigned projects with respect to timing, scheduling, and tracking.

    Directly leads or sets objectives for others on team projects and tasks, e.g., able to lead process working groups or Communities of Practice.

    coach or mentor more junior writers. Able to lead compound/submission/indication/DAS writing teams independently.


    Contacts Outside the Company:
    May oversee day-to-day project-related work of contractors or external service providers as needed. A university/college degree is required plus at least 12 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, PhD, MD) is preferred. At least 10 years of relevant medical writing experience is required. At least 2 years of people management experience if a people manager. Experience in project management and process improvement is required.

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