Senior Clinical Editor

ICON; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

ICON seeks a Senior Medical Editor to support a global biotech company, focusing on quality control of clinical documents. This home-based role involves copyediting, proofreading, and verifying data, ensuring compliance with submission standards. Candidates should have a Bachelor's degree and relevant experience in medical writing or editing.

Benefits

Annual leave entitlements

Health insurance options

Retirement plans

Global Employee Assistance Programme

Life assurance

Flexible benefits like childcare vouchers

Qualifications

• 3 years of experience in medical writing, QC, editing, or publishing within the pharmaceutical industry.

Responsibilities

• Perform QC review of clinical documents for compliance with style guides.
• Copyedit and proofread clinical documents for grammar and formatting.
• Verify data against source tables and ensure internal consistency.

Skills

Knowledge of editorial and publishing activities in Clinical Development

Proficiency in Microsoft Word

Experience with EDMS systems

Education

Bachelor’s degree in English, Basic Science, Business, or related field

Tools

Microsoft Word

PowerPoint

Excel

Visio

Adobe

Job description

As a Senior Medical Editor, you will support a global mid-sized biotech company. While employed stably with ICON, you will be fully embedded with our client.

The position is home-based anywhere in Europe or the UK. Your contribution will focus on solid and liquid tumors. Working for our client, you'll benefit from ICON's learning opportunities and potential for a long-term career.

This role involves quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Medical Editor will copyedit, proofread, format, and verify data in clinical documents according to SOPs and standards, potentially overseeing other editors, establishing schedules, and liaising with cross-functional authors. The activities require minimal oversight.

What you will be doing:

1. Perform QC review of documents (e.g., clinical study protocols, amendments, CSRs, Investigator's Brochures, Module 2 clinical summaries) to ensure compliance with style guides and submission standards.
2. Verify data against source tables, figures, and listings, and format tables according to standards.
3. Copyedit and proofread clinical documents for grammar, style, and formatting according to AMA and company guidelines.
4. Ensure internal consistency and accurate reporting of data, confirming statements reflect source documents or data (e.g., SAS tables).
5. Check reference lists, verify citation information, order references, add them to EDMS, and ensure cross-referencing.
6. Proofread documents against templates to ensure compliance with required sections and text.
7. Publish nonclinical and clinical documents and compile CSR appendices as needed.

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Bachelor’s degree in English, Basic Science, Business, or related field with 3 years of experience in medical writing, QC, editing, or publishing within the pharmaceutical industry.

Required skills include:

• Strong knowledge of editorial and publishing activities in Clinical Development.
• Proficiency in Microsoft Word, including formatting tables, cross-references, styles, and templates. Experience with PowerPoint, Excel, Visio, Adobe.
• Knowledge of Adobe PDF bookmarking and hyperlinking for submission standards.
• Experience with EDMS systems (e.g., Veeva Vault, SharePoint).

What ICON can offer you:

Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement plans
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Flexible benefits like childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, and more.