Senior Electronic Document Specialist
8 hours ago
About the Job Join Excelya where Audacity Care and Energy define who we are and how we work We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand This role is an exciting opportunity to contribute to a dynamic ambitious team in Medical Writing department You will play a critical part in driving innovation and making an impact in the Medical affairs space while enjoying a stimulating professional environment that encourages personal and intellectual growth Main Responsibilities The Senior Electronic Document Specialist SeDS takes a leadership role in coordinating and conducting quality control checks on prepared documents With experienced and well-defined input the SeDS ensures the accuracy completeness and submission readiness of documents including cross-references bookmarks and navigations Liaising with the Quality Control Specialist for the review of the formatting of the document Reviewing drafts and performing format submission readiness quality control Word and PDF Providing electronic versions of quality-checked drafts Providing additional writing editing and quality control services as required Compiling and hyperlinking study reports PDF including cross-references for appendices Assisting in publishing processes when required Collaborating with the Sponsor s team for document comments and suggestions Addition of cover pages and Table of Contents TOC in appendices Reconciling the list of appendices in the report body and updating the electronic TOC Mentors and provides guidance to eDS in document preparation review and submission Assists in the coordination of eDS processes Supports the training and development of eDS providing guidance and support on complex issues Liaising with internal groups such as Medical Affairs Biostatistics Data Management Regulatory Affairs Clinical and Quality Assurance to gather necessary information Requirements About You At Excelya we value curiosity precision and a collaborative spirit We re looking for someone eager to learn contribute and support high-quality document preparation within a dynamic environment Experience Experience in electronic document preparation quality control editing or medical writing for clinical regulatory documents e g CSRs protocols is considered an advantage Skills Strong analytical abilities and the capacity to interpret complex data Exceptional attention to detail and a rigorous work ethic Intellectual curiosity creativity and adaptability in fast-paced settings Excellent teamwork interpersonal communication and emerging leadership skills Advanced proficiency in English written and verbal Education University graduate in life sciences or related field Languages Professional use of English is mandatory both written and verbal Benefits Why Join Us At Excelya we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare Here s what makes us unique We are a young ambitious health company representing 900 Excelyates driven to become Europe s leading mid-size CRO with the best employee experience Our one-stop provider service model offering full-service functional service provider and consulting enables you to evolve through diverse projects Working alongside preeminent experts you will help improve scientific operational and human knowledge to enhance the patient s journey Excelling with care means benefiting from an environment that values your natural talents pushes boundaries with audacity and nurtures your potential allowing you to contribute fully to our shared mission
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bangalore, India Excelya Full timeAbout the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Writing department. You will play a...
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