Associate Director, Clinical Regulatory Writing (CReW)

AstraZeneca • Gaithersburg, MD

2d • Hybrid

About The Position

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. The Clinical Regulatory Writing Associate Director is expected to: Independently manage clinical regulatory writing activities across a portfolio of work. Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied. As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS). Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements. Be a strategic thinker and demonstrate strategic review capabilities. Proactively collaborative with other functions at the program level. Support the development of others in Clinical Regulatory Writing. Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.

Requirements

• Bachelor's degree in Life Sciences in an appropriate subject area
• Minimum of 5 years’ experience
• 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.

Nice To Haves

• Advanced degree in a scientific field (Ph.D.)

Responsibilities

• Independently manage clinical regulatory writing activities across a portfolio of work.
• Author clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
• Provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.
• Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.
• Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Be a strategic thinker and demonstrate strategic review capabilities.
• Proactively collaborate with other functions at the program level.
• Support the development of others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager