Medical Writing Clinical Publisher

Role Summary

Medical Writing Clinical Publisher — responsible for ensuring the accuracy and compliance of clinical documents for regulatory submissions, with expertise in clinical study protocols, clinical study reports, investigator's brochures, and summary modules. Requires experience in clinical document publishing or regulatory submission publishing, strong technical skills in Word and Adobe Acrobat, and familiarity with global regulatory submission standards (ICH, FDA, EMA).

Responsibilities

• Publish clinical and regulatory documents in compliance with regulatory guidelines and internal SOPs
• Ensure submission readiness of all clinical documentation through thorough technical QC (navigation, hyperlinking, bookmarks, headers/footers, metadata, PDF compliance, etc.)
• Check document formatting for consistency, accuracy, and adherence to corporate style guides and regulatory publishing standards
• Manage publishing of stand-alone documents and Clinical Study Reports (CSRs)
• Format documents using advanced Microsoft Word features and Adobe Acrobat Professional and plug-ins
• Manage document-level projects and smaller publishing projects/submissions with assistance
• Provide business support for Medical Writing systems (e.g., Veeva, PleaseReview, SharePoint)
• Provide templates, style guides, PleaseReview and other training to medical writers
• Understand processes and systems involved with publishing GRMW clinical documents
• Perform administrative or other responsibilities as needed
• Participate in cross-functional submission planning meetings and collaborate with Regulatory Operations and Medical Writing teams to drive alignment and efficiency; contribute to process optimization and SOPs

Qualifications

• Bachelor’s degree in life sciences or related field
• Minimum of 2 years of experience in clinical document publishing or regulatory operations publishing in pharma/biotech
• Working knowledge of ICH, FDA, EMA requirements related to clinical documentation, global submission processes (IND, NDA, MAA) and eCTD submissions
• Excellent English (written and spoken)
• Attention to detail, strong organization and communication skills
• Advanced proficiency in Microsoft Word (macros, templates, complex formatting) and Adobe Acrobat Professional (including plug-ins and validation tools)
• Strong organizational/planning and problem-solving skills at product and program level

Preferred

• Experience using Veeva Vault as an EDMS
• Familiarity with PleaseReview, SharePoint, and other collaborative authoring tools
• Experience developing or maintaining document templates and process documentation