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 reputed company 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 reputed company. 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/reputed company/regulatory requirements
• reputed company reputed company formatting of clinical documents according to SOP/reputed company/regulatory requirements. Insert tables if requested.
• Coordinate production and distribution of draft and final documents to project team and reputed company. Organize and reputed company delivery of reputed company deliverables.
• Ensure that reputed company work is complete and of high reputed company prior to delivery
• reputed company support on software and document reputed company issues to MWS staff as required

reputed company Control

• Ensure that reputed company work is complete and of high reputed company prior to team distribution or shipment to reputed company.
• Ensure document is submission reputed company as per the appropriate regulatory guidelines, and reputed company with departmental, corporate or reputed company SOPs and style guidelines, as applicable
• Under appropriate supervision as needed, reputed company 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 reputed company, 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 reputed company, and advance document publishing to approval, according to reputed company or reputed company guidelines/SOPs. Distribute final documents to project team and reputed company only if agreed.
• reputed company collection of documentation for assembly of project files and reputed company 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.
• reputed company administrative support if requested.

Skills:

• Excellent interpersonal, verbal and written communication skills, and good degree of initiative
• reputed company reputed company 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 reputed company 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 reputed company 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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