Senior Clinical Editor

4 months ago

Reading, United Kingdom Novasyte Full time

This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Clinical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors. The Senior Clinical Editor performs the activities with mínimal oversight needed.
- Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the sponsor and submission standards.
- Verify data in documents against the source tables, figures, and listings and format tables according to sponsor standards.
- Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and sponsor style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
- Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
- Proofread documents against the standard templates to ensure compliance with required sections and text.
- Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.
- Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
- May oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.
- Assist with training of more junior editors or contract staff.
- Strong working knowledge of the editorial and publishing activities within Clinical Development.
- Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.
- Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).
- Ability to effectively communicate with vendors and manage outsourced editorial work.
- Keen attention to detail.
- Ability to manage multiple activities, prioritize effectively, and work in a fast-paced, deadline-driven environment.
- Strong organizational and time management skills.
- Strong verbal, written, and interpersonal communication skills.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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