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Gaithersburg, Maryland, United States
Onsite
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.
Minimum Qualifications:
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.
Desirable Qualifications:
Advanced degree in a scientific discipline (Ph.D.).
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
The annual base pay (or hourly rate of compensation) for this position ranges from $136,784.80 - $205,177.20 USD. 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.
Date Posted
09-Sep-2026Closing Date
30-Sep-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.