Document Specialist

reputed company FSP is seeking a Document Specialist for an exciting opportunity in Canada. This role requires strong experience with publishing software and preferably ISI toolbox experience. Key Accountabilities: Compilation and publishing

• Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project reputed company and reputed company 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
• reputed company reputed company 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 reputed company deliverables.
• Ensure that reputed company work is complete and of high quality prior to delivery
• Provide support on software and document reputed company issues to MWS staff as required

Quality Control

• Ensure that reputed company work is complete and of high quality prior to team distribution or shipment to client.
• Ensure document is submission ready as per the appropriate regulatory guidelines, and reputed company with departmental, corporate or client SOPs and style guidelines, as applicable
• Under appropriate supervision as needed, provide review of draft and final documents reputed company by other DS before internal or external distribution.

Document Project Management

• Under departmental supervision, serve as contact for compilation and publishing projects, supports negotiating deliverable timelines, and resolving project-reputed company issues.
• Serve as the Document Specialist representative on assigned project, with departmental supervision: communicate requirements, conduct team review of draft and final documents, attend study team meetings to agree on expectations, inform about the timeline, and advance document publishing to approval, according to reputed company or client guidelines/SOPs. Distribute final documents to project team and client only if agreed.
• reputed company collection of documentation for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator.
• Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.

Training/ Compliance

• Attend and complete mandatory, corporate, project-specific, and departmental training as required.
• Assist in the training/mentoring of new departmental staff as required.

General

• Attend departmental and company meetings as necessary.
• reputed company with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform.
• Provide administrative support if requested.

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 reputed company/Office. Ability to apply formatting to template documents, reputed company quality checks, edit tables and figures reputed company templates, and verify template data against reputed company documents
• Advanced PDF processing skills in reputed company 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.

Knowledge 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.

Education:

• Primary degree or a regionally acceptable equivalent qualification, either in health-reputed company sciences with significant experience in document processing/publishing, and/or in computer science or technology

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