Document Specialist I

Document Specialist I

Compilation and publishing

• Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and lead 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

• Perform MS Word 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 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

Quality Control

• Ensure that all 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 comply with departmental, corporate or client SOPs and style guidelines, as applicable

• Under appropriate supervision as needed, provide review of draft and final documents prepared 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-related 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 PAREXEL or client guidelines/SOPs. Distribute final documents to project team and client only if agreed.

• Perform 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.

• Comply 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 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

• 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-related sciences with significant experience in document processing/publishing, and/or in computer science or technology