AstraZeneca
Clinical Regulatory Writer (Associate Director or Manager)
US - Boston - MA · Director
Sponsorship not specified$133k-$200kDetected 1 day ago
Strategic CommunicationsLeadershipCommunication
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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.
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About the role
- As a Clinical Regulatory Writer, you will 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.)
- Experience with CSR, CTD module 2 summaries
- Experience leading clinical submission (NDA/BLA/MAA)
- Experience developing clinical submission communication strategy
Compensation
- The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual for Associate Director level, and $ 113,293.60 - $169,940.40 USD Annual for Manager level.
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 or Manager Location: Boston, MA - 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.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.