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

AstraZeneca • Gaithersburg, MD

17d

About The Position

We are now recruiting a n Associate Director , R&I Clinical Regulatory Writing ( CReW ) . A s part of a clinical delivery or submission team, the Associate Director provide s strategic communications leadership to projects, establish es communication standards and best practice, and continuously advocate s for quality and efficiency. The Associate Director also a uthor s strategic clinical-regulatory documents and provid es 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:

Requirements

• A Bachelor's degree
• At least 5 years of e xperience 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.
• D rive 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 .

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: Director