Document Specialist

• 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
• Use departmental publishing software to produce electronic deliverables
• Perform MS Word formatting of clinical documents according to SOP/client/regulatory requirements
• 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
• Ensure document is submission ready as per the appropriate regulatory guidelines
• Provide review of draft and final documents prepared by other DS before internal or external distribution
• Serve as contact for compilation and publishing projects, supports negotiating deliverable timelines, and resolving project-related issues
• Serve as the Document Specialist representative on assigned project
• Perform collection of documentation for assembly of project files and client deliverables
• Attend and complete mandatory, corporate, project-specific, and departmental training as required
• Assist in the training/mentoring of new departmental staff as required
• Attend departmental and company meetings as necessary
• Comply with departmental procedures and requirements
• Provide administrative support if requested

• 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
• 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
• 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
• Advanced PDF processing skills in Adobe Acrobat
• Advanced skills in other document editing software
• 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

ISI toolbox experience

• Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
• Development and promotion based on global standards and your personal development plan
• Patient-focused in everything we do
• Supportive and inclusive environment
• Career growth and development
• Mentorship
• Flexible work
• Diverse projects
• Culture of excellence
• Global exposure