Senior Clinical Editor

IQVIA, Inc.; Reading; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading global provider of clinical research services is seeking an editorial support member for their Quality and Publishing team. The role involves editing and formatting clinical regulatory documents to ensure compliance with quality standards. Ideal candidates will have significant experience in the pharma sector, strong attention to detail, and proficiency in document management tools.

Qualifications

• At least 3 years of editing experience in the pharma and/or healthcare industry.
• Advanced knowledge of document formatting and editing in Microsoft Word.
• Proficiency with StartingPoint Templates and styles.

Responsibilities

• Provide editing and formatting support for clinical regulatory documents.
• Ensure documents adhere to the department's Style Guide and publishing requirements.
• Meet deadlines while maintaining high-quality standards.

Skills

Editing

Document Formatting

Proofreading

Attention to Detail

Communication Skills

Tools

Microsoft Word

Adobe Acrobat

Microsoft Teams

SharePoint

Document Management Systems

Job description

The position will be a member of the Quality and Publishing team in the Medical Writing department. This position reports to the Quality and Publishing Senior Manager. Under the general supervision of the Senior Manager, this role collaborates closely with Medical Writers and is responsible for providing editorial support for clinical regulatory documents created by in-house Medical Writers and Medical Writing vendors. The goal is to produce high-quality documents that adhere to internal and global quality standards and comply with electronic publishing standards.

Responsibilities

1. Provide editing and styling/formatting support to Medical Writers for clinical regulatory documents (e.g., CTD Submission documents, Clinical Study Protocols, Investigator's Brochures, Clinical Study Reports, Clinical Study Outlines, etc.).
2. Edit documents to align with the department's Style Guide, document-specific templates, and publishing requirements.
3. Ensure consistent styling and formatting throughout the documents and related materials, such as using StartingPoint Styles uniformly.
4. Support editing of other clinical/regulatory documents (e.g., SAP, CDP, Briefing Book) as needed.
5. Adhere to guidelines, SOPs, practices, and industry standards in all work aspects.
6. Assist in developing and reviewing standard processes and templates.
7. Meet deadlines while maintaining high-quality standards.

Essential Skills and Experience

1. At least 3 years of editing experience in the pharma and/or healthcare industry.
2. Advanced knowledge of document formatting and editing in Microsoft Word (MS Office suite).
3. Proficiency with StartingPoint Templates suite and styles.
4. Strong proofreading skills.
5. Proficiency in Adobe Acrobat.
6. Basic understanding of the drug development process and Good Clinical Practice (GCP).
7. Knowledge of routine document preparation, including style guides, regulatory guidance, and templates.
8. Familiarity with the AMA Manual of Style.
9. Ability to multi-task in a fast-paced environment under strict deadlines.
10. Flexibility, open-mindedness, and attention to detail.
11. Excellent verbal and written communication skills.
12. Experience with Microsoft Teams and SharePoint.
13. Experience with Regulatory/Electronic Document Management Systems (e.g., Documentum).
14. Experience with ISI Toolbox and publishing is a plus.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com