Associate Director, R&I Clinical Regulatory Writing (CReW)
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Job Location:
Gaithersburg, MD - USA
Monthly Salary:
$ 136784 - 205177
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
We are now recruiting anAssociateDirectorR&IClinical Regulatory Writing (CReW).As part of a clinical delivery or submission teamthe Associate Directorprovidesstrategic communications leadership to projectsestablishescommunication standards and best practice and continuously advocatesfor quality and efficiency.The Associate Director also authorsstrategic clinical-regulatory documents and providescritical review to achieve high-quality standardsutilizingbest practices for document and accelerated submission delivery.
WhatYou willDo
The AssociateDirectorCReW isexpected to:
Independently manage clinical regulatory writing activities across a portfolio of work.
Author clinical-regulatory documents within a program by ensuring that relevant regulatorytechnicaland 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 clearconciseandaccuratemessages that address information requirements.
Be a strategic thinker anddemonstratestrategic 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 includingrepresentingtheClinical Regulatory Writing functionon drug and non-drug projects as.
Minimum Qualifications:
ABachelors degree
At least 5 years of experiencein the medical/regulatory writing field gained in a pharmaceutical/biotech industry orContract Research Organizationenvironment.
Experienceleadingsubmission authoring andauthoring submission level documents.
Understanding ofthedrug development process fromdevelopmentthrough life-cycle management.
Experience inworking withinandcontributing tolarge diversematrixteams.
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 circumstancesandlatest information.
Desirable Qualifications:
Advanced degree in a scientific discipline (Ph.D.).
Why AstraZeneca
At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.
So whats next
Are you already imagining yourself joining our team Good because we cant wait to hear from you!
The annual base pay (or hourly rate of compensation) for this position ranges from $136784.80 - $205177.20 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 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
11-Feb-2026Closing Date
25-Feb-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
