Document Specialist II null

Job Description

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles, and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.

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 the 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 before team distribution or shipment to the client.
• Ensure the document is submission-ready as per the appropriate regulatory guidelines, and complies with departmental, corporate, or client SOPs and style guidelines, as applicable
• Provide suggested alternative compilation or publishing methods when contributors provide a document that does not meet document needs.
• Provide a 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 resolve 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 the project team and client only.
• Provide solutions to internal or external clinical teams for queries related to the word or PDF formatting under minimum supervision.
• Identify any potential project challenges to departmental line management and project leader, including changes in the 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.
• Guide 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
• Attend departmental and company meetings as necessary.
• Comply with departmental procedures and requirements, such as completion of project assignments and workload trackers on the applicable software platform.
• May participate in departmental or interdepartmental process improvement and training initiatives, including the development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow
• 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.