We are now recruiting a Manager, Clinical Regulatory Writing (CReW). The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core 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.
The Clinical Regulatory Writing Manager is expected to:
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With limited guidance, lead document authoring, 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 standard methodology are applied.
Can 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 collaborative with other functions and external service providers/contractors during document development.
As part of a clinical delivery team, provide communications support to projects, establish communication standards, and best practice, and continuously advocate for 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 mentorship and support of more senior members of the group.
Minimum Qualifications:
Life Sciences degree in an appropriate subject area.
We require a minimum of 3 years’ experience
Experience in medical writing.
Strong communication and leadership skills.
Knowledge of the technical and regulatory requirements related to the role.
Essential Qualifications:
Advanced degree in a scientific field (PhD)
Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.
If this sounds like the type of organization where you would like to grow your career and make a real difference to patients, then we would like to hear from you; apply today!
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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