Senior Medical Writer
hace 3 días
Barcelona
Job Overview Por favor, asegúrese de leer completamente el resumen y los requisitos de esta oportunidad de empleo que se detallan a continuación. Acts as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements, meeting agreed timelines. Performs Senior Review of straightforward medical writing deliverables and negotiates timelines while resolving customer comments. Provides written and verbal feedback to junior staff and, when appropriate, to customers. Keeps abreast of current medical and technical writing and regulatory knowledge, including Good Clinical Practice (GCP), and developments in drug development and medical/technical writing. Essential Functions • Take a leading role in preparing assigned documents: confirm scope, templates, and specifications; negotiate and adhere to timelines; organize document reviews; communicate directly with the customer., • Plan and organize workload for assigned projects and tasks: identify project needs, track timelines, and implement customer requests., • Lead meetings on more challenging topics independently., • Present on standard Medical Writing processes at full‑service bid defense meetings., • Assist in training and development of junior staff, formally as a mentor or ad hoc for local colleagues. May develop and deliver training to the global team on a topic of specific expertise and contribute presentations on Medical Writing to other IQVIA groups., • Act as Project Manager for a more complex, single Medical Writing project, including Project Finance/Invoicing responsibilities., • Complete project finance activities, including monitoring and forecasting budgeted hours., • Propose, review and approve budgets and costings for routine projects, estimating hours needed for Medical Writing tasks., • Take on a small customer lead role or assist an established partnership lead in their role., • Represent region or site on a Medical Writing initiative or cross‑functional initiative., • Facilitate and brainstorm the identification of new ideas; may represent Medical Writing at a general capabilities audit. Qualifications • Bachelor’s Degree in life sciences related discipline or related field., • Master’s Degree in life sciences related discipline or related field., • Ph.D. in life sciences related discipline or related field., • Typically requires at least 3 years of highly relevant experience and related competency levels., • In‑depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents, with the ability to identify deficiencies, errors, and inconsistencies., • Good understanding of common statistical methods used in clinical trials and interpretation of their results., • Ability to review a statistical analysis plan effectively and identify deficiencies, errors, and inconsistencies in statistical output., • Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner., • Significant experience as a lead writer in preparing CSRs and protocols, receiving consistently positive feedback from customers and colleagues., • In‑depth knowledge of drug development, medical writing, and associated regulations; good understanding of statistical principles and medical terminology across therapeutic areas., • Excellent written and oral communication skills, including grammatical and technical writing proficiency., • Excellent attention to detail and accuracy., • Confident and effective communication and negotiation skills with customers and project managers., • Ability to deliver difficult messages constructively., • Demonstrates initiative and sound judgment when faced with unfamiliar project/document situations or challenges., • Demonstrated abilities in collaboration with others and independent thought., • Demonstrates confidence and maturity in routine medical writing situations., • Demonstrates good judgment in requesting input from senior staff., • Ability to establish and maintain effective working relationships with coworkers, managers, and customers., • Ability to effectively manage multiple tasks and projects., • Ability to proactively evaluate risks and potential issues, seek solutions, and discuss them appropriately with colleagues and customers. xcskxlj, • Must be computer literate. #J-18808-Ljbffr