Manager, Clinical Regulatory Writing

Job Description

Job Title: Manager, Clinical Regulatory Writing

Career Level: D

Introduction to role

Are you ready to lead a team in delivering high-quality clinical regulatory documents? As a Manager in Clinical Regulatory Writing, you will provide communications expertise, primarily focusing on document development with occasional contributions to communication strategy at the program level. You will also play a key role in improvement projects, driving critical communication excellence to achieve successful submissions and approvals.

Accountabilities

The Clinical Regulatory Writing team offers expert mentorship on clinical-regulatory documents for drug projects. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry-leading organization driving critical communication excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing Manager is expected to:

• With limited guidance, lead author and ensure the timely delivery of high-quality clinical regulatory documents such as CSPs, CSRs, IBs, Module 2.7 submission documents, briefing documents, pediatric plans, regulatory response, and specific documents supporting established brands.
• Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practices are applied.
• Balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
• Drive the clinical interpretation of data and information and condense it into clear, concise, and accurate messages that address customer information requirements.
• Provide critical review of documents for correctness, clarity, completeness, and compliance.
• Proactively collaborate with other functions during document development, including, as needed, with external service providers/contractors.
• Join the clinical delivery team to support project communications, set communication standards, and consistently promote quality and efficiency.
• Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required.
• Work independently but with the guidance and support of more senior members of the group.

Essential Skills/Experience

• Life Sciences degree in an appropriate discipline.
• Experience in medical communications.
• Strong communication and leadership skills.
• Knowledge of the technical and regulatory requirements related to the role.

Desirable Skills/Experience

• Advanced degree in a scientific discipline (Ph.D).
• Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

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 are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration with academia, biotechs, and industry experts to create swift impacts on disease. We offer varied opportunities for lifelong learning and career development while working on pioneering projects that have never been done before.

Ready to make an impact? Apply now to join our team!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.