Clinical Regulatory Writer, Associate Director
AstraZeneca
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Maryland • Massachusetts • United States
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Salary
💰 $133,042 - $199,564 per year
Job Level
About the role
- 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
Requirements
- BS Life Sciences degree in an appropriate discipline
- Significant (7+ yrs) medical writing experience in the 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
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage in accordance with the terms of the applicable plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical regulatory writingmedical writingcommunication strategydata interpretationdocument authoringquality standardsregulatory requirementsstrategic thinkingproject managementcontinuous improvement
Soft Skills
leadershipcollaborationadvocacycommunicationstrategic thinkingproblem-solvingteam managementorganizational skillsefficiencyproactive engagement
Certifications
BS Life Sciences degree