Manager, Clinical Regulatory Writing

Job title:

Manager, Clinical Regulatory Writing

Company:

AstraZeneca

Job description

Role holders provide communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level. They contribute to improvement projects.AccountabilitiesThe 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:

• With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents.
• Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
• Have the ability to 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.
• 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 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.AstraZeneca is where you can make a big impact! Be part of a dedicated Oncology team that’s growing fast and building a strong track record of success. Our pioneering approach focuses on early-stage cancer trials, listening to patients’ needs, and evolving based on their feedback. We are deeply committed to transforming lives with the ultimate aim of eliminating cancer as a cause of death. Here, we are uniquely placed with the funding, ambition, and bravery to make it happen.Ready to join us? Apply now!Date Posted 18-mar-2025Closing Date 07-abr-2025AstraZeneca 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.

Expected salary

Location

Barcelona

Job date

Thu, 20 Mar 2025 00:13:32 GMT

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