Medical Writer I

This is a fully remote position, open to applicants in United Kingdom, +3 more states.

📋 Description

• Conduct Quality Control (QC) on the Trial Master File (TMF) to ensure readiness for inspections and adherence to ICH guidelines and GxP standards.

• Manage EndNote libraries and literature references to aid medical writing tasks.

• Provide support throughout the entire Clinical Study Report (CSR) lifecycle, which includes coordinating narratives, managing appendices, and ensuring submission readiness.

• Format draft tables and documents for medical writers.

• Execute document QC checks against original source materials.

• Develop Document/Submission Plans and maintain publishing trackers.

• Finalize document formatting and perform technical checks to guarantee submission readiness.

• Oversee document workflows within the Electronic Document Management System (EDMS), which includes uploading, version control, approvals, and compliance monitoring.

• Act as a technical resource and subject matter expert regarding document management system processes and protocols.

• Collaborate with functional area teams to manage workflows and approve documentation.

• Provide guidance to clinical research teams on regulatory EDMS and publishing requirements.

• Plan and execute assignments independently.

• Prepare, perform quality control, and manage the lifecycle of clinical and regulatory documents in a GxP-compliant R&D environment.

• Assist with processing documents within the EDMS.

⛳️ Requirements

• A Bachelor’s degree or 3–5+ years of relevant experience is mandatory; a background in a scientific field is preferred.

• Experience in preparing documents for submission using Regulatory/EDMS platforms, such as Veeva Vault, is advantageous.

• Proficient working knowledge of Adobe Acrobat and Microsoft Word.

• Advanced computer skills are essential.

• Expert-level knowledge of Microsoft Word, including the use of templates, automation, and styles.

• Familiarity with Adobe QC tools.

• Proficiency with AI tools is preferred.

• Understanding of document template usage and maintenance.

• Knowledge of electronic submission requirements for regulatory agencies and records management practices.

• Awareness of ICH E3 and E6 guidelines.

• Familiarity with CFR 21 Part 11 regulations.

• Capability to handle multiple projects at once.

• Ability to independently plan and carry out assignments.

• Must have the legal right to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans available.

• Life assurance and disability coverage provided.

• Employee assistance programs and wellbeing resources offered.

• Opportunities for learning and development through structured training and career pathways.

• An inclusive and accessible workplace environment.

• Reasonable accommodations during the recruitment process are available.