Associate Director, Clinical Regulatory Writing (CReW)

AstraZeneca; Gaithersburg (MD); On-site; USD 137,000 - 205,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation and holidays

Health benefits (medical, dental, and

On-site fitness center

Job summary

AstraZeneca's Gaithersburg, MD site seeks an Associate Director of Clinical Regulatory Writing to lead regulatory writing across programs, ensuring quality and timely submissions.

The role requires deep medical writing expertise, strategic leadership, and collaboration across functions to drive efficient development and lifecycle management of therapies.

Qualifications

• 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.
• 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 regulatory, technical, and quality standards.
• Provide strategic communications leadership to projects and establish standards and best practices.
• Lead submission strategy and coordinate internal/external authoring teams.
• Drive the clinical interpretation of complex data into clear messages for stakeholders.
• Support development of others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective.

Skills

Medical writing

Regulatory writing

Communication leadership

Project leadership

Drug development knowledge

Education

Bachelor's degree in Life Sciences

Ph.D. in a scientific field

Job description

Associate Director, Clinical Regulatory Writing

Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting‑edge technology and lab spaces, all designed to inspire collaboration and cross‑functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full‑service cafeteria and copy center. This is where you’ll find newly‑designed, activity‑based work spaces to suit a variety of working styles while increasing collaboration between teams.

About the Role

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 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.

Minimum Qualifications

• 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.

Desired Qualifications

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

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio‑pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

Compensation and Benefits

The annual base pay (or hourly rate of compensation) for this position ranges from $136,784.80 - $205,177.20 USD Annual. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. In addition, our positions offer a short‑term incentive bonus opportunity; eligibility to participate in our equity‑based long‑term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Equal Employment Opportunity

Our 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.