Post : Document Specialist I
Job Description:
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.
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
• Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, under the 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.
• Perform all scanning/uploading of paper documents
• Be responsible for conversion of documents to PDF format
• 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.
• Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, under the 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.
• Perform all scanning/uploading of paper documents
• Be responsible for conversion of documents to PDF format
• 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.
