Manager - Clinical Regulatory

3 weeks ago

Bengaluru, India AstraZeneca Full time
About the roleRole 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.

Typical 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 essential communication excellence to achieve successful submissions and approvals.

The

Manager II,

Clinical Regulatory Writing

is expected to:With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents such as CSPs, CSRs, IBs, BDs, 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.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 collaborative 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

Education, Qualifications, Skills and ExperienceEssentialLife 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.

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

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