Quick Jobs

Compilation and Publishing

• 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.

• 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

• Organize and track delivery of appendices and any other documents as required

• 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.

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

• Provide suggested alternative compilation or publishing methods when contributors provide document that does not meet document needs.

• Provide review of draft and final documents prepared by other DS before internal or external distribution.

Document Project Management

• Serve as primary contact for compilation and publishing projects supports negotiating deliverable timelines and resolving project-related issues.

• Serve as the lead Document Specialist on assigned project teams demonstrate document leadership; coordinate and communicate compilation and publishing requirements conduct team review of draft and final documents schedule and lead/facilitate study team meetings to agree on expectations evaluate progress on tasks identify issues and facilitate resolutions manage/drive the timeline.

• Advance document publishing to approval according to PAREXEL or client guidelines/SOPs. Distribute final documents to project team and client only.

• Provide solutions to internal or external clinical teams for queries related to word or PDF formatting under minimum supervision.

• Identify any potential project challenges to departmental line management and project leader including changes in project plan timeline or out of scope requests and suggest possible resolution options.

• 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.

• Build and maintain collaborative relationships with teams/clients for an efficient productive and professional working relationship.

• Manage document technology program needs for specific client projects and interface with client and project teams as necessary

Training/Compliance

• Attend and complete mandatory corporate project-specific and departmental training as required.

• Provide guidance to new staff as well as less experienced departmental members.

• Provide recommendations on process improvement relating to publishing activities as required.

Knowledge and Experience

• Has worked with and has 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.