Medical Writer I

We are currently seeking Medical Writer I to join our diverse and dynamic team. At this role you will be responsible for end-to-end preparation, quality control, and lifecycle management of clinical and regulatory documents within a GxP-compliant R&D environment. This Medical Writer assists as needed with ensuring that documents are processed within the Electronic Document Management System (EDMS). The ideal candidate will be an early-career professional with a strong interest to develop and grow into a Medical Writer role

What You Will Be Doing:

• Perform Trial Master File (TMF) Quality Control (QC) ensuring inspection readiness and compliance with ICH guidelines (E3, E6)/GxP requirements for documents prepared by medical writers (MWs)
• Maintain EndNote Libraries and literature reference to support medical writing activities
• Support full CSR lifecycle including narrative coordination, appendices management, and submission readiness
• Support for MW with formatting of draft tables and documents
• QC checks of documents against source materials
• Document/Submission Plan preparation (trackers for Publishing)

• Final formatting of documents and technical checks for submission readiness
• Manage document workflows within EDMS (e.g., Veeva Vault), including upload, version control, approvals, and compliance tracking

Serve as a technical resource

• Manage multiple projects simultaneously and be a subject matter expert in document management system processes and procedures, which include granular clinical study reports and other regulatory documents; act as a liaison with functional area teams to manage workflows and approve documents.
• Serve as a technical expert for clinical research teams regarding the regulatory EDMS and regulatory publishing requirements
• Independently plan and execute assignments

Your Profile:

• Bachelor’s degree or 3-5+ years of related experience is required; scientific field preferred
• Experience in the preparation of documents for submission using Regulatory/EDMS preferred, e.g., Veeva Vault
• Strong working knowledge of Adobe Acrobat and Microsoft Word is essential
• Advanced computer proficiency required, including expert knowledge of Microsoft Word (templates, automation, styles) and adobe QC tools.
• Proficiency with AI tools, preferred  
• Working knowledge of the use and maintenance of document templates
• Knowledge of requirements for electronic submissions to regulatory authorities and records management required (e.g., ICH (E3 &E6), CFR 21 Part 11)

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