Associate Director, Clinical Regulatory Writing

AstraZeneca

US - Gaithersburg - MD permanent

Posted: February 6, 2026

Job Description

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.

Accountabilities

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.

Essential Skills/Experience

• 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.

Desirable Skills/Experience

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

Annual base salary for this position ranges from $136,784.80 to $179,530.05. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

Date Posted

05-Feb-2026

Closing Date

11-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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