Medical Writer

Overview

Responsibilities

• The Medical Writer will be responsible for the independent development of a range of clinical trial and real-world evidence documents.
• Designing and developing retrospective and prospective clinical study protocols and protocol amendments.
• Development of study concepts, synopses, and feasibility documents.
• Development and review of informed consent forms (ICFs).
• Authoring and contributing to retrospective and prospective clinical study reports (CSRs).
• Review and contribution to tables, figures, and listings (TFL) shells and narrative content, in collaboration with biometics and biostatistics team.
• Work closely with clinical operations, biometrics/biostatistics, and regulatory teams to ensure accurate and timely delivery of documents.
• Manage multiple documents and projects in parallel, ensuring timelines are met.
• Participate in internal and external review cycles and address comments efficiently and accurately.
• Engage directly with internal stakeholders and, where required, sponsors and investigators to support document development.
• Ensure all documents comply with applicable regulatory guidelines, internal SOPs, and templates.
• Maintain high standards of scientific accuracy, clarity, and consistency.
• Support document version control and internal quality review processes.

Qualifications

• Bachelor’s or Master’s degree in a life sciences or related discipline (e.g. pharmacology, biology, biochemistry, physiology, genetics, or similar).
• Minimum of 4 years of experience as a Medical Writer within a pharmaceutical company or Contract Research Organisation (CRO).
• Demonstrated experience independently authoring clinical trial documents, including protocols, ICFs, and study reports.
• Experience in real-world evidence (RWE) or observational research writing, including protocols and study reports.
• Strong working knowledge of ICH-GCP and relevant regulatory guidelines (e.g. ICH, FDA, EMA).
• Ability to manage multiple projects and deliver high-quality documents to tight timelines.
• Excellent written and verbal communication skills.
• Strong attention to detail, organisation, and time-management skills.
• Confidence working independently while collaborating effectively within cross-functional teams.
• GCP certification preferred.