Medical Writer

BioTalent; United Kingdom; Remote; GBP 50,000 - 70,000; Part time

Job summary

A leading consulting firm is looking for a Quality Management Documentation Senior Specialist to oversee the development and maintenance of GxP Quality Management Documents. This remote role requires a Bachelor's in life sciences and at least 3 years of experience with document management systems. The ideal candidate has strong communication skills and attention to detail. This position offers a contract-based engagement with flexible working arrangements.

Qualifications

• Minimum of 3 years of experience with document management systems.
• Experience managing GxP procedural documents.
• Technical writing or editing experience is preferred.

Responsibilities

• Perform document control activities ensuring compliance.
• Manage external distribution of QMDs for audits and inspections.
• Collaborate with stakeholders to uphold compliance.

Skills

Attention to detail

Strong communication skills

Critical thinking

Teamwork

Interpersonal skills

Education

Bachelor’s degree in life sciences or related discipline

Tools

Microsoft Word

Excel

SharePoint

PowerPoint

Visio

Job description

Overview

Senior Consultant- Key Account Management (Contract)

Job Title: Quality Management Documentation Senior Specialist

Location: Remote

Contract Type: Contract

About the Role

We are seeking a Quality Management Documentation Senior Specialist to support the development and maintenance of GxP Quality Management Documents (QMDs) in compliance with a global Quality Management System (QMS). This role requires exceptional attention to detail, strong communication skills, and the ability to work to tight timelines while ensuring accuracy and compliance.

Responsibilities

• Perform document control activities, ensuring consistency and compliance with applicable standards and procedures for QMD lifecycle management.
• Manage external distribution of QMDs to support project teams, audits, and inspections.
• Collaborate with internal stakeholders to ensure compliance with QMS and QMD lifecycle requirements.
• Format, QC, and publish QMDs and related deliverables with exceptional accuracy.
• Proofread and edit QMDs to ensure clarity, accuracy, and adherence to internal standards.
• Identify and correct errors and formatting issues.

Qualifications

• Bachelor’s degree in life sciences or a related discipline.
• Minimum of 3 years of experience with document management systems.
• Experience managing GxP procedural documents.
• Strong proficiency with Microsoft Word, Excel, SharePoint, PowerPoint, and Visio.
• Excellent written and verbal communication skills.
• Strong critical thinking, teamwork, and interpersonal skills.
• Experience in technical writing or editing is preferred.
• Familiarity with Visio or similar diagramming tools is a plus.
• Understanding of the drug development process is desirable.