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Document Specialist I | |
Medical Writing | |
pare-10033676 | |
India - Karnataka - Bangalore | |
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You’ll be surrounded by supportive leadership and a brilliant team who share a common goal — to improve the lives of millions of patients. | |
Key Accountabilities • Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, under the supervision of the project lead Medical Writer. Work with internal or external Clinical and/or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines. • Perform all scanning/uploading of paper documents • Be responsible for conversion of documents to PDF format • Use departmental publishing software to produce electronic deliverables to ensure insertion of navigability features, and accurate intra-document hyperlinking, according to SOP/client/regulatory requirements • Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements. Insert tables if requested. • Coordinate production and distribution of draft and final documents to project team and client. Organize and track delivery of all deliverables. • Ensure that all work is complete and of high quality prior to delivery • Provide support on software and document related issues to MWS staff as required Skills • Excellent interpersonal, verbal and written communication skills, and good degree of initiative • Client focused approach to work • Flexible attitude with respect to work assignments and new learning • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Ability to work in a matrix environment and to value the importance of teamwork • Advanced word processing skills in MS Word/Office. Ability to apply formatting to template documents, perform quality checks, edit tables and figures within templates, and verify template data against source documents • Advanced PDF processing skills in Adobe Acrobat • Advanced skills in other document editing software, such as design and application of styles/templates, graphics, and integration with other applications • Proficient in document management systems and key publishing software • Proficiency in basic grammar, punctuation, and spelling. Understanding of medical and pharmaceutical terminology desired. • Advanced keyboard skills Education • Primary degree or a regionally acceptable equivalent qualification, either in health-related sciences with significant experience in document processing/publishing, and/or in computer science or technology Language Skills • Fluent in written and spoken English | |
Good knowledge of word processing and publishing software with proven ability (15-17 pages per hour of formatting and post PDF work). Experience with processing multiple clinical documents of varying complexity such as clinical trial submission dossiers, clinical study reports, etc., as an independent document technologist or specialist. |
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Wednesday, 11 June 2014
Document Specialist I....PAREXEL..h7
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