Job as Senior Document Specialist in PAREXEL
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
* 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
* 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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