Clinical Regulatory Writer, Associate Director / Manager
AstraZeneca•Gaithersburg, MD
•$133,042 - $199,564•Hybrid
About The Position
Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals.
Requirements
- Associate Director level: BS Life Sciences degree or similar, 7+ yrs medical writing experience in pharmaceutical industry or CRO.
- Manager level: BS Life Sciences degree or similar, 2-7+ yrs medical writing experience in 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.
Nice To Haves
- Advanced degree in a scientific discipline (Ph.D.)
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.
- Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.
- Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.
- Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.
- Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements.
- Demonstrate strategic thinking and review capabilities.
- 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.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Manager
