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.