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In this role you will provide expert leadership for clinical regulatory writing across programs, guiding submission strategies and cross-functional collaboration. You’ll coach and develop a team of leads and writers to drive compliant, high-impact submissions aligned with project goals. You will shape best practices for document delivery and act as a subject-matter expert in regulatory communications across therapeutic areas. This is a senior, strategic role with scope to influence processes and talent development.
Compensaciones / Ventajas
• Provide expert leadership across a group of submissions or programs, overseeing the communication strategy
• Drive the use and sharing of drug and disease-specific knowledge across teams and a network of Program Leads
• Identify commonalities/differences in communication strategy across programs and optimize approaches
• Influence stakeholders to establish best communications practices across a TA or Business Unit
• Lead submission activities when acting as a submission lead or lead authoring key documents
• Review key submission documents for consistency of messaging
• Support training, risk mitigation, and continuous improvement of Clinical Regulatory Writing
• Drive resourcing strategy and interface with medical writing vendors in contracting and oversight
• Support recruitment and onboarding for new group members
• In line management role: set objectives, drive performance development, and manage recruitment/onboarding
Responsabilidades
• Life Sciences degree in an appropriate discipline
• Significant experience in medical/regulatory writing within pharmaceutical/biotech xqbhyrx or CRO environments
• Experience authoring/editing and managing multiple regulatory documents and submissions
• Broad cross-functional understanding of drug development from scientific, technical, and business perspectives
• In-depth knowledge of technical and regulatory requirements relevant to the role
• Strong communication with stakeholders inside and outside AstraZeneca
• Conceptual/strategic thinker with strong networking skills
• Ability to work with vendors to deliver on budget, quality, time, and cost
Requisitos principales
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