Medical Writer - Patient-Centric Endpoints (PCE)

IQVIA ,
Reading, Berkshire
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Job Description

Join us on our exciting journey! IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. The Medical Writer for Patient Centered Endpoints supports client projects and internal IQVIA thought leadership initiatives by undertaking writing of regulatory briefing books, dossiers, responses to consultation issued by regulatory or payer bodies, abstracts, posters, manuscripts, patient-directed summaries and presentations as an integrated member of the project team. The role participates in a portfolio of projects and maintains high standards of scientific output and effective process management to all project deadlines. RESPONSIBILITIES Technical responsibilities * Develop outlines and drafts of abstracts, posters, manuscripts and presentations with oversight and review from senior project team members. * Integrate the multiple arguments and evidence streams developed by a project team and develop well-structured, clear, and concise regulatory briefing documents and evidence dossiers. * Participate in both internal and external project team meetings. * Facilitate appropriate internal and external (client and/or experts) review of assigned documents and take responsibility for on-time delivery. * Manage formal requirements of document production and review cycles including formats and procedures such as ICMJE, GPP and company SOPs. * May perform QC review of documents or parts of documents prepared by other staff. * Participate as a lead writer on several project teams concurrently and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff. * Keep abreast of COA-related research and regulatory framework. * Other responsibilities * Perform other qualitative tasks such as literature review or production of study reports (qualitative and quantitative). * Support proposal writing and business development activities. * Maintain proficiency of skills and knowledge and remains current with industry trends based current literature, application of new technology, attendance at professional meetings, etc. * May deliver basic level writing training to small groups or individuals within IQVIA. * REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Understanding and interest in health outcomes research principles, clinical outcomes assessments including PROs, ClinROs, ObsROs and PerfOs, and the use of digital technology in this field (eCOAs), and familiarity with the literature. * Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results. Familiar with qualitative research studies and quantitative studies for clinical outcome assessments (psychometrics and outcomes analyses). Ability to develop publications related to any of these fields. * Experience in the use of key literature databases (e.g., PubMed, Cochrane) and the conduct of literature reviews. * Experience with publication management software such as DatavisionTM or PubSTRAT is desirable. * Strong scientific writing skills and ability to communicate fluently and effectively in English, both in writing and verbally. * Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner and to present a line of argument and explanation as required in regulatory documents and publications. * Careful attention to detail and accuracy. * Competence in completing good first draft documents within a standard timeframe with limited guidance. * Must be computer literate with knowledge of Microsoft Office applications including Word, PowerPoint and Excel, and of Bibliographic software such as EndNote. * Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple tasks and projects. * Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * A minimum of a Master's degree or educational equivalent in in psychology, epidemiology, educational psychology, outcomes research, sociology, medicine, medical science or related field is required. * A minimum of 3 years work experience in roles with some scientific writing responsibilities. * A minimum of 1 year work experience in the patient-centered (clinical outcomes assessment) field. We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you

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