Clinical Development Lead

As a Senior Document Controller, you will:

• Lead the development, authoring, review, and life cycle management of clinical and performance evaluation documentation.
• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Labelling, and R&D teams to ensure alignment of clinical evidence strategies.
• Author and review critical regulatory documents including:
• Performance Evaluation Plans and Reports
• Clinical Study Protocols
• Clinical Study Reports
• Investigator Brochures
• Regulatory submission documentation
• Conduct scientific literature reviews and evaluate published clinical evidence.
• Synthesise complex clinical, laboratory, and scientific data into clear, concise, and regulatory-ready reports.
• Support clinical evidence generation activities in accordance with applicable regulatory requirements, including IVDR.
• Provide scientific expertise and guidance to cross-functional project teams.
• Drive documentation quality, consistency, and compliance throughout the product development life cycle.

• Advanced degree (PhD, PharmD, MSc, MD, or equivalent) in Life Sciences, Pharmacology, Biomedical Engineering, Biostatistics, Epidemiology, Clinical Research, or a related scientific discipline.
• Significant experience in scientific, medical, or clinical writing within the pharmaceutical, biotechnology, medical device, or diagnostics industry.
• Demonstrable experience authoring clinical and regulatory documentation for global regulatory submissions.
• Strong understanding of clinical research methodologies and evidence generation processes.
• Experience interpreting and communicating complex scientific and clinical data to a range of stakeholders.
• Excellent written communication and document management skills.
• Strong project management and organisational capabilities, with the ability to manage multiple projects simultaneously.
• Proven ability to work effectively within multidisciplinary and cross-functional teams.
• Familiarity with regulatory environments including IVDR, GCP, and applicable clinical research regulations., While not mandatory, the following qualifications and experiences will be advantageous:
• Experience working within in-vitro diagnostics (IVD) or medical devices.
• Publication history within peer-reviewed scientific journals.
• Experience supporting global regulatory submissions.
• Knowledge of Performance Evaluation documentation under IVDR.
• Experience using AI-enabled tools and technologies to support literature reviews, scientific analysis, and document preparation while maintaining scientific accuracy and regulatory compliance.

If you’re ready to take on this exciting challenge and drive customer insights forward, we’d love to hear from you! Apply today to join a forward-thinking organisation that values innovation and excellence.