Associate Director, R&I Clinical Regulatory Writing (CReW)

AstraZeneca • Gaithersburg, MD

19d

About The Position

We are now recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice, and continuously advocates for quality and efficiency. The Associate Director also authors strategic clinical-regulatory documents and provides critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery.
What You will Do
The Associate Director, CReW, 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.
Drive the development of the clinical Submission Communication Strategy.
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 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 Clinical Regulatory Writing function on drug and non-drug projects, as required.

Requirements

• A Bachelor's degree
• At least 5 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment.
• Experience leading submission authoring and authoring submission level documents.
• Understanding of the drug development process from development through life-cycle management.
• Experience in working within, and contributing to, large, diverse, matrix teams.
• Excellent verbal and written communication skills in English.
• In depth knowledge of the technical and regulatory requirements related to the role.
• Flexibility in adapting to changing circumstances and latest information.

Nice To Haves

• Advanced degree in a scientific discipline (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.
• Drive the development of the clinical Submission Communication Strategy.
• 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 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 Clinical Regulatory Writing function on drug and non-drug projects, as required.

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

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