Document Specialist I (Bloemfontein, South Africa)
Parexel International Corporation
Bloemfontein, Orange Free State, South Africa
The Document Specialist I will provide document technology support on Medical Writing projects as appropriate. Some specific responsibilities include compilation of appendices to clinical study reports and similar documents, document formatting and post PDF work, document scanning/uploading, preparation of electronic appendices using departmental publishing workstation, and organizing and tracking all deliverables. The Document Specialist I must be conscientious, able to work with minimal supervision, have an aptitude for working with a variety of different software applications and systems, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle matters of a confidential nature.
* Compilation and Publishing
• Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and 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.
• Understands global regulatory submission formats, industry standards, and guidelines, and publishing best practices
• 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
* Quality Control
* Document Project Management
* Training / ComplianceQualificationsKnowledge and Experience:
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.
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.
• 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.