PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
POST: Senior Document Specialist
Job Description:
* Independently compile appendices to clinical study reports in compliance with appropriate regulatory requirements. 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 scanning and 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
* Organize and track delivery of appendices, and any other documents as required
* Ensure all deliverables are complete and of high quality prior to distribution to both internal and external clients
* Work with IT and Validation groups to ensure maintenance of software and hardware owned by MWS, including tracking and validation of software updates. Perform the Designated Responsible Individual (DRI) role for MWS software, if requested.
* Train and mentor junior members of the team on processes and deliverable requirements, as required
* Provide subject matter expertise to MWS management, Medical Writers and other Document Specialists, when required
* Support MWS management in collection and reporting of metrics and other departmental tasks as appropriate
Experience:
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, connecting with a broad range of cultures
* 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
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* 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. Experience with advanced tools for publishing such as ISI Toolbox, Core Dossier, and related plug-ins, is an advantage.
* Experience in working on clinical submission documents, clinical study reports, protocols, appendices, etc., and assembly of electronic submissions in compliance with technical editorial and format requirements
* Proficiency in basic grammar, punctuation, and spelling. Understanding of medical and pharmaceutical terminology desired.
* Advanced keyboard skills
Education
- Primary degree, 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.
Minimum Work 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.
Additional Information:
Location: Karnataka - Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 4th Apr, 2013
Req Number: pare-10024925
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