Hybrid Barcelona: Program Lead, Clinical Regulatory Writing

AstraZeneca GmbH; Barcelona; Híbrido; EUR 120.000 - 160.000; Jornada completa

Descripción de la vacante

AstraZeneca GmbH in Barcelona is seeking a Director, Clinical Regulatory Writing (Program Lead) to provide expert communications leadership across clinical programs and drive submission strategies.

You will lead a team of writers, coordinate with medical writing vendors, ensure messaging consistency, and drive improvements in regulatory writing standards while aligning with project goals across multiple therapeutic areas.

Formación

• Significant regulatory writing experience in pharma/biotech with increasing responsibility.
• Broad cross-functional understanding of drug development and regulatory requirements.
• Ability to communicate with stakeholders within AstraZeneca and beyond.

Responsabilidades

• Provide expert leadership across a group of submissions or programs.
• Drive information sharing and optimize submission strategies across teams.
• Lead submission activities as a primary submission lead when required.
• Mentor Clinical Regulatory Writers and manage risks and training.
• Interface with vendors and manage externalized work to budget and quality.

Conocimientos

Cross-functional leadership

Strategic thinking

Vendor management

Regulatory writing expertise

Educación

Life Sciences degree

Advanced degree in scientific discipline (Ph.D.)

Descripción del empleo

AstraZeneca GmbH in Barcelona is seeking a Director, Clinical Regulatory Writing (Program Lead) to provide expert communications leadership across clinical programs and drive submission strategies.

You will lead a team of writers, coordinate with medical writing vendors, ensure messaging consistency, and drive improvements in regulatory writing standards while aligning with project goals across multiple therapeutic areas.