Document Specialist

Document Specialist I

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel has an exciting opportunity for a Document Specialist I! The Document Specialist I will provide document technology support on Medical Writing projects as appropriate. Some specific responsibilities include compilation of appendices to clinical study reports and similar documents, document formatting and post PDF work, document scanning / uploading, preparation of electronic appendices using departmental publishing workstation, and organizing and tracking all deliverables. The Document Specialist I must be conscientious, able to work with minimal supervision, have an aptitude for working with a variety of different software applications and systems, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle matters of a confidential nature.

Key Accountabilities

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 :

Document Project Management :

Training / Compliance :

General :

Skills :

Knowledge and Experience :

Education :