Associate Director II, CReW

AstraZeneca; India; In loco; INR 4.000.000 - 6.500.000; Tempo pieno

Descrizione del lavoro

AstraZeneca plc seeks an Associate Director II, CReW to provide strategic leadership and expert regulatory writing across a complex portfolio of clinical drug programs. You will author and review high‑impact regulatory documents, drive submission communications strategy, and collaborate with cross‑functional teams to ensure high-quality submissions.

The role requires significant medical writing experience in pharma or CRO, with strong leadership and regulatory knowledge.

Competenze

• 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.

Mansioni

• Lead clinical regulatory writing across a complex portfolio, prioritizing impact and timely delivery.
• Lead author for the most complex clinical-regulatory documents meeting technical, regulatory, and quality standards.
• Drive the clinical Submission Communication Strategy (cSCS) with cross-functional alignment.
• Provide strategic communications leadership and set standards across programs.
• Collaborate with clinical, biostatistics, regulatory, safety, and operations teams to craft clear messages.
• Lead internal and external authoring teams including vendor medical writers.
• Shape clinical narratives across studies and indications from protocol to label.
• Support development of Clinical Regulatory Writing Managers and coach teams.
• Drive continuous improvement in authoring models, tools, and ways of working.

Conoscenze

Strategic leadership

Regulatory writing leadership

Communication leadership

Cross-functional collaboration

Formazione

Life Sciences degree

Ph.D. desired

Descrizione del lavoro

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-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.

Why AstraZeneca:

At AstraZeneca's Biopharmaceuticals R&D, we are part of the solution, turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.