Associate Director, Clinical Regulatory Writing
$128.49k - $168.64k per yearAstraZeneca
Associate Director for Clinical Regulatory Writing at AstraZeneca's Mississauga office, leading strategic communications and authoring regulatory documents for clinical programs. The role requires managing writing activities across a portfolio while driving submission strategies and mentoring internal teams.
Responsibilities
- Independently manage clinical regulatory writing activities across portfolio
- Author clinical-regulatory documents while ensuring regulatory and quality standards
- Develop and drive clinical Submission Communication Strategy
- Lead internal and external authoring teams and manage vendor medical writers
- Support development and mentoring of other clinical regulatory writers
Requirements
- Life Sciences degree in relevant discipline
- Minimum 5 years medical or regulatory writing experience in pharma, biotech, or CRO
- Proven experience leading submission authoring and submission-level documents
- Understanding of drug development process from development through lifecycle management
- Excellent written and verbal English communication skills
- In-depth knowledge of technical and regulatory requirements
- Advanced degree (PhD) in scientific discipline preferred
Compensation: $128,488–$168,640.50 base annual salary
Vacancy posted 8 days ago
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