Location

La siguiente información tiene como objetivo proporcionar a los posibles candidatos una mejor comprensión de los requisitos para este puesto.
Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to role
The Director, Clinical Regulatory Writing (Program Lead) provides expert communications leadership across clinical programs and drives effective collaboration and growth within Clinical Regulatory Writing.

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 strategic communication excellence to achieve successful submissions and approvals.

Program Lead Responsibilities

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- Provide expert leadership across a group of submissions or programs, overseeing the communication strategy.
- Drive the use and exploitation of information by sharing drug and disease‑specific knowledge and experience across program and submission teams and through a network of Program Leads.
- Identify commonalities and differences in communication strategy, content and process across multiple programs or submissions, and optimize approaches.
- Influence stakeholders at the highest levels of the organization, eg, to establish best communications practices across a TA or Business Unit.
- Be a leader within the disease area or drug programs. Set clear direction while advising others and develop innovative solutions in highly complex situations (eg, drug programs with multiple indications/combinations).
- Lead submission activities when acting as a submission lead (eg, authoring clinical submission communication strategies) or lead authoring other key documents

📌 Associate Director (Barcelona)
🏢 Astrazeneca
📍 Barcelona