Associate Director II, CReW

Job Title: Associate Director II, CReW Global Career Level: E3 Role Type: Individual Contributor Work Location: Embassy Manyata Business Park About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. About the role Introduction to role: The role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high-quality standards. They represent the skill on drug and non-drug projects. 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 critical communication excellence to achieve successful submissions and approvals. Accountabilities: Portfolio Leadership: Independently manage clinical regulatory writing across a complex portfolio, prioritizing impact and ensuring delivery to time and quality. Authoritative Document Ownership: Serve as lead author for the most complex clinical-regulatory documents in a program, meeting all technical, regulatory, and quality standards while applying best practice and continuous improvement. Submission Communications Strategy: When acting as submission lead, drive the clinical Submission Communication Strategy (cSCS), aligning cross-functional teams around clear positions and messages that anticipate regulator needs. Strategic Communications Partnership: As part of clinical delivery and submission teams, provide strategic communications leadership, set communication standards, and champion quality, efficiency, and consistency across programs. Cross-Functional Collaboration: Partner closely with clinical, biostatistics, regulatory, safety, and operations teams to interpret complex data and craft concise, accurate messages that answer customer and regulator questions. Vendor and Team Leadership: Lead internal and external authoring teams, including vendor medical writers, to scale delivery while upholding scientific integrity and message discipline. Program-Level Influence: Operate proactively at the program level, shaping clinical narratives across studies and indications and ensuring coherence from protocol to label. Talent Development: Support the development of Clinical Regulatory Writing Managers, sharing frameworks, feedback, and coaching to set the standard across the skill. Operational Excellence: Drive continuous improvement in our authoring model, tools, and ways of working, representing the writing skill in drug and non-drug projects for broader organizational benefit. Essential Skills/Experience: • Life Sciences degree in an appropriate subject area. • Minimum 10+ years of significant medical writing experience in the pharmaceutical industry or CRO. • Ability to advise and lead communication projects. • Understand drug development and communication process from development, launch through life cycle management. • In depth knowledge of the technical and regulatory requirements related to the role. Desirable Skills/Experience: • Advanced degree in a scientific field (Ph.D.). When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changin