Senior Medical Writer - Patient Centered Endpoints

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. PURPOSE The Senior Medical Writer for Patient Centered Endpoints supports client projects and internal IQVIA thought leadership initiatives by undertaking writing of regulatory briefing books, dossiers, abstracts, posters, manuscripts and presentations as an integrated member of the project team. The role acts a senior advisor on writing deliverables to the project team and coaches and develops junior members of the Medical Writing 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 limited review required 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 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 with extensive knowledge of COA-related regulatory and scientific framework. + Take responsibility for execution of assigned projects to a high standard. + Review and monitor resource requirements for assigned projects and support effective delivery of the project within budget. + Identify the best suitable staff resources for projects and any knowledge or capability gaps. + Give guidance to less experienced team members and assists in their training and development. + May act as Project Manager for patient-centered-endpoint projects where the core of the task is a written deliverable. + Present at international congresses when needed. + May propose revisions to SOPs or suggest process improvements for consideration. Other responsibilities + Line manager responsibilities for 1-3 medical writers + 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 and to external clients. + Provide input into the PCE team business and strategic development. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES + Understanding and interest in health outcomes research principles, clinical outcomes assessments including PROs, ClinROs, ObsROs and PerfOs, and familiar 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). + Proven experience in the use of key literature databases (e.g., PubMed, Cochrane) and the conduct of literature reviews. + Proven scientific writing skills and ability to communicate fluently and effectively in English, both in writing and verbally. + Familiar with the structural and content requirements of patient-centered-endpoints related project deliverables particularly for those with an important scientific writing component (e.g., COA dossier, briefing book, etc.). Knowledge of regulatory COA-related guidance documents. + 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. + Demonstrated ability and experience to work independently on patient centered endpoints-related projects. + Must be computer literate with knowledge of Microsoft Office applications including Word, PowerPoint and Excel, Bibliographic software such as EndNote and of publication management software such as DatavisionTM or PubSTRAT. + Must be able to work in a fast-paced environm

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