Medical Writing Director
2 days ago
Job Summary
The Associate Director, Medical Writing will lead medical writing activities for all development programs at Vera Therapeutics, Inc. This individual will be responsible for producing high-quality regulatory and clinical documents that meet industry standards and regulatory requirements.
Key Responsibilities:
- Developing and implementing medical writing strategies to ensure timely and effective delivery of regulatory and clinical documents
- Collaborating with cross-functional teams, including regulatory affairs, clinical and nonclinical development, and project management, to support all aspects of key regulatory and clinical document production
- Ensuring compliance with US and international regulatory requirements and guidance associated with clinical and regulatory documents
- Staying current with product regulatory guidance documents and assisting with procedure gap assessments
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