Director, Clinical Regulatory Writing

Director, Clinical Regulatory Writing: A Strategic Leadership Opportunity in Cambridge, UK

For experienced regulatory writing professionals seeking to elevate their impact, this Director, Clinical Regulatory Writing position presents a compelling opportunity. Located in the vibrant scientific hub of Cambridge, UK, this role offers a chance to lead transformative projects and shape the future of life-changing medicines.

Key Advantages for Aspiring Candidates:

• Strategic Influence: As a Director, you will be instrumental in developing and executing communication strategies for high-priority programs. This role demands and rewards the ability to influence stakeholders at all organizational levels, establishing best practices and driving excellence in clinical-regulatory documentation.
• Leadership and Mentorship: This position offers a unique blend of individual contribution and team leadership. You will have the opportunity to mentor and coach a team of talented writers, fostering an environment of productivity, engagement, and continuous professional development within core therapeutic areas.
• End-to-End Project Involvement: From early-phase planning to final submission, you will be deeply involved in the entire drug development lifecycle. This comprehensive exposure ensures a holistic understanding of the process and the satisfaction of seeing breakthrough science translated into tangible patient solutions.
• Oncology Focus: A significant advantage for candidates with a passion for oncology, this role requires and further develops deep expertise in oncology drug development, including a thorough understanding of crucial endpoints.
• Innovation and Best Practice Development: The role actively encourages the development and implementation of best practices for the Clinical Regulatory Writing organization. This includes exploring and potentially leveraging advanced tools, such as AI, for medical writing, positioning you at the forefront of industry innovation.
• Collaborative and Inclusive Environment: AstraZeneca fosters a culture where bold thinking is encouraged through the collaboration of diverse teams. The emphasis on in-person working (a minimum of three days per week) facilitates connection, rapid progress, and the challenging of perceptions, balanced with individual flexibility.

Key Considerations for Your Career Path:

• Advanced Scientific Foundation: A minimum Master's degree in a scientific discipline is essential, with a PhD strongly preferred. This highlights the need for a robust scientific understanding to excel in this role.
• Extensive Document Authoring & Management Experience: Proven proficiency in authoring, editing, and managing the review of a wide range of clinical regulatory documents is critical. This includes experience with INDs, NDAs, health authority responses, and specific documents like clinical study protocols, pediatric investigational plans, and various Clinical Study Reports (CSRs).
• Demonstrated Oncology Expertise: A must-have requirement is a thorough understanding of oncology drug development and knowledge of oncology endpoints. Candidates without this specific expertise will find it challenging to meet the core requirements.
• Strong Program Management & Stakeholder Skills: The ability to manage multiple programs effectively and to communicate and influence a diverse range of internal and external stakeholders is paramount.
• Adaptability to Modern Tools: While experience with AI tools for medical writing is desirable, a willingness and ability to learn and adapt to new technologies will be beneficial for staying ahead in this evolving field.
• Team Management Experience: While desirable, direct line or team management experience will be a significant asset, enabling a smoother transition into the leadership aspects of this role.

This Director, Clinical Regulatory Writing position is an exceptional opportunity for a seasoned professional to lead, innovate, and contribute significantly to bringing life-changing medicines to patients. If you are driven by science, possess a strong regulatory writing background, and are eager to make a substantial impact, this role warrants serious consideration for your career advancement.