Senior Medical Editor FSP

Senior Medical Editor

Location:

Madrid, Spain

This role focuses on quality control review of clinical documents for submission to health authorities worldwide, ensuring compliance with SOPs, client style guides, and regulatory standards. The Senior Medical Editor supports the editorial team by managing workloads, mentoring junior staff, and driving process improvement initiatives.

• Perform QC review of documents (clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, and Module 2 clinical summary documents) to ensure compliance with the client style guide and submission standards.
• Verify data in documents against source tables, figures, and listings and format tables according to client standards.
• Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and client style guides.
• Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data.
• Check reference list in documents, verify citation information versus Pub Med, order copies of references, add to the electronic document management system (EDMS), and ensure 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 compile required CSR appendices as needed.
• Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
• Oversee the workload for editors, establishing schedules and interacting with cross‑functional authors.
• Assist with training of junior editors or contract staff.

• Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 8+ years of experience in a discipline directly related to document production (e.g., medical writing, QC, editing, publishing).
• Strong working knowledge of editorial and publishing activities within Clinical Development.
• Proficient in Microsoft Word, including formatting tables, inserting cross‑references, applying styles, and using templates. Experience with PowerPoint, Excel, Visio, Adobe.
• Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission‑ready standards.
• Experience in using an EDMS (e.g., Veeva Vault or SharePoint).
• Ability to effectively communicate with vendors and manage outsourced editorial work.
• Keen attention to detail.
• High level of English.

Equal Opportunity

Employer:

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.