Senior Medical Editor

This is a fully remote position, open to applicants in Spain.

📋 Description

• Conduct quality control reviews of documents (such as clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure adherence to the client Style Guide and submission standards.

• Validate data within documents against source tables, figures, and listings, and format tables in accordance with client standards.

• Edit and proofread clinical documents for grammar, style, and formatting in line with AMA and client style guidelines.

• Ensure internal consistency and verify that data is reported accurately, with statements correctly reflecting source documents or data (e.g., SAS tables and listings).

• Review reference lists in documents, including verifying citation information against PubMed, ordering copies of references, and adding them to the electronic document management system (EDMS), while ensuring each reference is cross-referenced within the document.

• Proofread documents against standard templates to guarantee compliance with required sections and text.

• Publish nonclinical and clinical documents and compile necessary CSR appendices as needed.

• Lead and actively engage in process improvement initiatives and provide assistance to Medical Writing staff with additional tasks as appropriate.

• Potentially manage the workload of editors, setting schedules and collaborating with cross-functional authors.

• Assist in training junior editors or contract staff.

⛳️ Requirements

• Bachelor’s degree in English, Basic Science, Business, or another analytical field combined with 4 years of relevant experience in the pharmaceutical industry, OR 8+ years of experience in a field directly related to document production (e.g., medical writing, QC, editing, publishing).

• Strong understanding of editorial and publishing processes within Clinical Development.

• Proficient in Microsoft Word, including skills in formatting tables, inserting cross-references, applying styles, and utilizing templates.

• Familiarity with PowerPoint, Excel, Visio, and Adobe.

• Strong knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.

• Experience using an EDMS (e.g., Veeva Vault or SharePoint).

• Ability to effectively communicate with vendors and manage outsourced editorial tasks.

• Exceptional attention to detail.

• High proficiency in English.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and advancement opportunities.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Commitment to fostering an inclusive culture.