Associate Director, Clinical Regulatory Writing

AstraZeneca • Gaithersburg, MD

55d • Hybrid

About The Position

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to role Are you ready to lead strategic communications in clinical drug programs? As an Associate Director in Clinical Regulatory Writing, you'll provide leadership and expertise in authoring high-quality clinical-regulatory documents. Your role will be pivotal in ensuring these documents align with project strategies and regulatory requirements, representing the skill on both drug and non-drug projects. The Clinical Regulatory Writing team is at the forefront of providing expert communications leadership to drug projects. As an Associate Director, you will manage clinical regulatory writing activities across a portfolio, ensuring that documents meet regulatory, technical, and quality standards. You'll lead submission teams, drive the development of communication strategies, and collaborate with internal and external authoring teams. Your strategic thinking will be crucial in interpreting complex data and delivering clear messages that meet customer information needs. Additionally, you'll support the development of others in the team and drive continuous improvement in communications leadership.

Requirements

• Life Sciences degree in an appropriate discipline.
• 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 discipline (Ph.D).

Responsibilities

• Manage clinical regulatory writing activities across a portfolio, ensuring that documents meet regulatory, technical, and quality standards.
• Lead submission teams
• Drive the development of communication strategies
• Collaborate with internal and external authoring teams
• Interpret complex data and delivering clear messages that meet customer information needs
• Support the development of others in the team
• Drive continuous improvement in communications leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees