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Document Specialist II
Parexel International Corporation
Bengaluru, Karnataka, India
Compilation and publishing • Independently compile appendices to clinical study reports in compliance with appropriate regulatory requirements with minimal/no supervision of the project 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.
• 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
• 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 Document Specialist representative on assigned project teams, demonstrate document leadership, with departmental supervision (if needed):
communicate content requirements, coordinate and communicate requirements, conduct team review of draft and final documents, schedule and lead/facilitate study team 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.
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.
• Take up additional responsibility as and when 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.
• May participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflowQualificationsPrimary 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.
Job posted: 2020-11-10