Quanticate UK - Head Office

  • Senior Medical Writer

    Job Locations UK-Cheshire-Wilmslow
    Posted Date 1 week ago(8/6/2018 11:00 AM)
    ID
    2018-1690
    # of Openings
    1
    Category
    Medical Writing
  • Overview

    Carry out assigned medical writing projects under the direction of a Principal Medical Writer or above.

     

    Responsibilities

    Document Writing and Review

    • Provide leadership on preparation and review of medical writing documents, as well as the processes and standards required, to both colleagues and clients
    • Produce well-written, high-quality, timely medical writing documents that conform with current Quanticate (or client-specific) SOPs and processes, as well as applicable regulatory requirements and/or guidelines
    • Ensure medical writing documents accurately reflect the data, source information, and any document-specific requirements, and review statistical outputs and source information as needed
    • Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and adequately addressed
    • Review (including peer and QC review) medical writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed
    • Proof-read and provide editorial support on documents produced by other departments in Quanticate or by clients, if requested

    Project Management

    • Provide project management and/or oversight on medical writing projects and/or cross-functional projects using project management tools and processes
    • Independently plan, organise and prioritise workload to deliver multiple projects simultaneously within agreed timelines, while maintaining profitability
    • Collaborate effectively with project teams (including peer and QC reviewers) to ensure timely and efficient completion of projects
    • Using project management tools, drive and track project milestones and metrics
    • Complete (and approve) daily timesheets, providing (and ensuring) an accurate record of time spent on activities

     

     

    Process Improvement

    • Significantly contribute to best practice and process improvement by independently identifying opportunities/challenges and leading process improvement initiatives
    • Lead the development and implementation of medical writing standards, processes, guidelines and templates ensuring updates occur when and where appropriate

     

     

     

     

     

    Qualifications

      • Preferably 5 years experience preparing medical writing documents in the pharmaceutical industry, biotechnology or medical sector
      • Significant knowledge and experience on regulatory requirements and/or guidelines for scientific communications
      • Demonstrated ability to mentor others
      • Published author of scientific literature desirable
      • Excellent written and verbal communication skills with the ability to convey complex concepts and information in a logical and concise manner

     

      • Excellent attention to detail

     

      • Excellent organisational skills with ability to manage priorities and work effectively and efficiently under pressure

     

      • Excellent analytical skills with a balanced approach to problem-solving, using flexibility and persistence as appropriate

     

      • Self motivated to work independently on projects 

     

      • Assertive with good negotiation and influencing skills

     

      • Demonstrated judgement and decision-making skills

     

      • Dedicated team player with strong interpersonal skills

     

      • Proficient using Microsoft Office applications, version control, document management and reference management

     

    • Strong interest in continued self learning in the areas of science/medicine and medical writing topics/trends
    • Willingness to learn and be open to new ideas

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