Quanticate UK - Head Office

  • Senior Medical Writer

    Job Locations UK-Hertfordshire-Hitchin | UK-Cheshire-Wilmslow | UK-Home Based
    Posted Date 3 weeks ago(10/5/2018 10:41 AM)
    # of Openings
    Medical Writing
  • Overview

    We are looking for a Senior Medical Writer to join our dedicated Medical Writing team!


    This position can be home or office based.





    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







    • 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




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