AstraZeneca
Clinical Regulatory Writer, Associate Director / Manager
US - Gaithersburg - MD · Director
Sponsorship not specified$133k-$200kDetected 1 day ago
Strategic CommunicationsLeadershipCommunication
> stay_score
odds of building a lasting career here
64Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines.
- That's why we work, on average, a minimum of three days per week from the office.
- But that doesn't mean we're not flexible.
Responsibilities
- Independently manage clinical regulatory writing activities across a complex portfolio of work.
- Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met.
- Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.
- Collaborate proactively with other functions at the program level.
- Support the development of Clinical Regulatory Writing Managers.
- Drive continuous improvement and operational excellence from a communications leadership perspective.
- Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
Requirements
- In-depth knowledge of the technical and regulatory requirements related to the role.
Skills
- Advanced degree in a scientific discipline (Ph.D.)
Compensation
- The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual.
Benefits
- offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
- Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.
Company info
- Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role: Are you ready to be part of the solution, turning drug development strategies into reality?
- Apply now and be part of our dynamic team!
Equal opportunity
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Apply directly at AstraZeneca →Create a free account for alerts like thisView AstraZeneca immigration profile
This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.