Job Description

JOB DESCRIPTION Job Overview Act as a Subject Matter Expert (SME) for IQVIA colleagues and clients in the area of Clinical Trial Disclosure and take a leading role in providing consultancy and practical support to clients in meeting their Clinical Trial Disclosure-related obligations. Essential Functions . Act as Lead Disclosure Specialist for the preparation and/or coordination of assigned tasks to a high standard, including, but not limited to, clinical trial results postings, working in accordance with IQVIA SOPs and the applicable regulatory requirements. . Participate in both internal and external project team meetings and liaise directly with the customer on disclosure issues and setting of timelines, as appropriate with limited supervision. Identify the needs of the project, negotiate and track project timelines, and implement client requests. Offer proactive solutions and advice to customers. . Takes responsibility for managing workload for assigned tasks, in collaboration with senior staff. . Maintain expertise in all elements of Clinical Trial Disclosure consultancy and support services, keeping abreast of developments in the Disclosure area to maintain our ability to provide consultancy to customers. A broad understanding of the requirements for protocol registration, maintenance, lay summaries, and document redaction is required. . Liaise effectively with other functional groups with involvement in disclosure-related activities (e.g. Medical Writing, Regulatory & Start-Up, Global Patient & Site Solutions, Biostatistics, Privacy Analytics), to ensure a clear understanding of respective responsibilities and accountabilities. . Review and monitor budget for assigned projects, including out of scope activities, and ensure that revenue is recognized as appropriate. . Perform QC and/or senior review of documents or parts of documents prepared by other members of the Clinical Trial Disclosure group, including, but not limited to, clinical trial results postings. Give feedback and guidance to less experienced colleagues and contribute to their technical training and development. . May deliver training to small groups or individuals within IQIVA on the role of the disclosure specialist and specific processes and/or client requests regarding Clinical Trial Disclosure. . Complies with Company SOPs and participates in the implementation of new SOPs. May propose revisions to SOPs or suggest process improvements for consideration. Qualifications . Bachelor\'s Degree Life science-related discipline or related field (Required) Req . At least 2.5 years\' broad-ranging experience as a medical/technical writer, regulatory affairs professional, or closely related position within a pharmaceutical environment, including practical experience in disclosure-related activities Req . Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. . Knowledge of all regulations relevant to Clinical Trial Disclosure, and to Medical Writing, including the structural and content requirements of CSRs. Note: requirements may evolve as the regulations evolve. . Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. . Good understanding of common statistical methods used in clinical trials and/or interpretation of their results. . Ability to give a presentation to a project team and/or customer on disclosure-specific topics. . Ability to identify deficiencies, errors, and inconsistencies in documents. . Ability to identify deficiencies, errors, and inconsistencies in statistical output in relation to the requirements of the clinical trial results postings. . Confidence in building relationships with customer and liaising directly with customers in person, via email or on the telephone. . Can provide thorough, appropriate and sensitive feedback to peers upon request to review a document. . Ability to assess workload and suggest prioritization to senior staff. . Ability to work on several projects at once while balancing multiple and overlapping timelines. . Demonstrated abilities in collaboration with others and independent thought. . Careful attention to detail and accuracy. . Must be computer literate. . Ability to establish and maintain effective working relationships with co-workers, managers and clients. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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