Medical Writer - Clinical and Regulatory Documentation (Remote, Part-Time)

Role Overview

We are seeking a Medical Writer to join our regulatory writing team on a part-time (0.6 FTE) contractual basis. This remote position is open to candidates based within the UK or Europe. The primary focus will be on preparing and quality-assuring documentation related to WHO submissions and ATC classification projects.

Key Responsibilities

• Create, review, and perform quality control on regulatory and scientific documents that support WHO submission activities.
• Collaborate closely with teams across Regulatory Affairs, Clinical, and Pharmacovigilance departments.

Required Experience and Skills

• Two to three years of experience in medical writing within pharmaceutical, biotechnology, or regulatory consultancy sectors.
• Demonstrated ability to generate precise clinical and regulatory documents under tight deadlines.
• Experience navigating global regulatory processes, especially WHO submission pathways.
• Knowledge and experience with ATC classification and verification protocols.
• Capability to interpret and distil complex clinical and scientific information for diverse audiences.
• Strong detail orientation, including expertise in document quality control, version management, and referencing.
• Effective communication skills for engaging with multi-disciplinary teams including Regulatory Affairs, Clinical, and Pharmacovigilance stakeholders.
• Authorization to work in either the UK or EU.
• Proven ability to work autonomously and prioritize tasks in a remote, part-time contract environment.