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Lead Document Specialist
3 months ago
Provides base-level support with limited supervision as a member of a team when making
recommendations and decisions. This position contributes to decisions that have an impact on the quality
and timeliness of moderate to complex document deliverables
Responsibilities
• Provides support as described in base level with limited supervision and advanced knowledge of complex publishing services.
• The single point of contact for the authoring community and subject matter expert to delivering submission-ready documents for assigned areas of responsibility.
• Responsible for managing document deliverables for assigned areas which involves working with the authoring community to determine timelines (ie, dossier or project planning) and assessment of resource needs.
• Strong interpersonal skill with a service-oriented attitude and ability to interact effectively with all levels of the organization in an inter-disciplinary environment.
Services include, but are not limited to, the technical preparation of submission documents
(individual documents and compound documents). Meets internal document standards with regard
to formatting, timeliness, and submission readiness, with some direct guidance.
• Provides publishing services of documents using industry standard publishing tools, including submission ready formatting, hyper-linking, and bookmarking.
• Provides document management services including management of documents in the submissions document repository, indexing and archiving of approved documents in accordance with quality standards.
• Performs technical QC.
• Knowledgeable in all aspects of submission-readiness requirements and department processes.
Qualifications/Experience
• 7+ years of experience in document processing activities in the pharmaceutical industry/CRO industry .
• Knowledge of publishing software, electronic document management systems, and intra- and interdocument linking. Strong word-processing skills and proficiency with MS Office and Adobe Acrobat.
• Knowledge of templates and complex document formats.
• In-depth understanding of the document-level processes, and guidelines that impact those processes.
• Proficiency in submission-related HA and Industry regulations and guidelines, as relevant.
• Effective organizational, interpersonal, teamwork, and communication skills
Ability to work or lead in a matrix environment and influence stakeholders.
• Knowledge and skills to build productive relationships across the organization and with external stakeholders.
• Demonstrated problem solving, troubleshooting, and adaptability
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
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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