Manager, Clinical Regulatory Writing (CVRM)

Are you ready to make a meaningful impact on people's lives with life-changing medicines? We are seeking a Manager, Clinical Regulatory Writing (CReW) to join our Biopharmaceuticals R&D team. This role offers the opportunity to provide expert communications leadership to drug projects and author strategically important clinical-regulatory documents. You will be instrumental in supporting the Company's CVRM therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals. What you'll do As a Manager, Clinical Regulatory Writing, you will lead authorship and ensure the timely delivery of high-quality clinical-regulatory documents. It is your task to ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied. It is important to have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities. You are expected to drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements. As well as provide critical review of documents for correctness, clarity, completeness and compliance. It will require you to proactively collaborate with other functions during document development, including, as needed, with external service providers/contractors. As part of a clinical delivery team, you will provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. Essential for the role - Life sciences degree in an appropriate subject area. - Experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment. - Understand drug development and communication process from development, launch, and life cycle management. - Knowledge of the technical and regulatory requirements related to the role. - Excellent verbal and written communication skills in English. - Flexibility in adapting to changing circumstances or new information. - Ability to work independently with support of more senior members and/or as part of a team. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we believe in turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions. Are you ready to join a team with deep specialist knowledge and Regulatory expertise? We welcome your application no later than 2nd august, 2024!