AstraZeneca looking for Clinical Regulatory Writing Manager

AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.

Post : Manager, Clinical Regulatory Writing

Job Description
Accountabilities
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 essential 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 standard methodology 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.

Candidate Profile
• Life Sciences degree in an appropriate subject area.
• Experience in medical communications.
• Strong communication and leadership skills.
• Knowledge of the technical and regulatory requirements related to the role.
• Advanced degree in a scientific discipline (Ph.D).
• Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

Additional Information
Qualification : Life Sciences degree
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-222565
End Date : 11-Apr-2025