Medical Writer

Overview M42 is a global health champion powered by artificial intelligence (AI), technology and genomics to advance innovation in health for people and the planet. Headquartered in Abu Dhabi, M42 combines its specialized, state-of-the-art facilities with integrated health solutions like genomics and biobanks, and harnesses advanced technologies to deliver precise, preventive and predictive care, to disrupt traditional healthcare models and positively impact lives globally.

Insights Research Organization & Solutions (IROS) is the UAE’s first homegrown Contract Research Organization (CRO) dedicated to advancing healthcare research. By delivering world-class clinical trials, data-driven solutions, and regulatory expertise, IROS empowers innovation, accelerates drug and therapy development, and strengthens the region’s role in shaping the future of global healthcare.

The Medical Writer will play a key role in supporting the delivery of both clinical trial and real-world evidence (RWE) studies at IROS. This is an independent role, with responsibility for leading the development of high-quality medical writing deliverables across multiple projects in parallel. The role is designed to support business growth by increasing writing capacity and ensuring that study documents are delivered to a high standard and within agreed timelines. The Medical Writer will work closely with other IROS medical writers, cross-functional teams and external stakeholders, and will be expected to take ownership of assigned documents from concept (study design) through to finalisation.

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.