Job Description
Contract: Initial 12 Months (Outside IR35) Location: Burgess Hill (Hybrid Working, up to 3 days per week on site) Rate: 49.73 - 86.09 per hour (Outside IR35) We are seeking an experienced Clinical Development Lead (Scientific and Medical Writing) to support the delivery of clinical evidence programmes within a global diagnostics environment. This role will play a key part in the development of clinical and performance evaluation documentation required to support regulatory submissions and product development activities. Working across Clinical Development, Regulatory Affairs, Quality, RandD, and Medical Affairs teams, you will lead the creation of high-quality scientific and regulatory documentation that supports innovative diagnostic solutions and advances patient care. Key Responsibilities:As a Senior Document Controller, you will: Lead the development, authoring, review, and lifecycle management of clinical and performance evaluation documentation.Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Labelling, and RandD teams to ensure alignment of clinical evidence strategies.Author and review critical regulatory documents including:Performance Evaluation Plans and ReportsClinical Study ProtocolsClinical Study ReportsInvestigator BrochuresRegulatory submission documentationConduct scientific literature reviews and evaluate published clinical evidence.Synthesise complex clinical, laboratory, and scientific data into clear, concise, and ..... full job details .....