PAREXEL Medical Writing job, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant PAREXEL and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Explore careers at PAREXEL.
Post : Document Specialist I
Job Description:
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.
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.
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Candidate Profile
• 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.
• 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.
Additional Information:
Location: Bengaluru, Karnataka
Functional Area: Medical Writing
Industry Type: Pharma
Req Number: 44071BR
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