Director, Medical Writing
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Job Description
Director of Medical Writing at Madrigal Pharmaceuticals focusing on leading medical writing initiatives for clinical trials and regulatory documents related to MASH therapies.
Responsibilities:
- Provide strategic medical writing leadership for documents supporting Phase 1 through IV clinical trials
- Collaborate closely with cross-functional teams to synthesize development strategies into study designs
- Author documents with a precise eye for detail and accuracy for global regulatory requirements
- Contribute to the development and implementation of processes and systems to optimize efficiency and productivity in document development
- Stay current with regulatory guidelines, industry trends, and best practices in medical writing
Requirements:
- At least 12 years of clinical or regulatory medical writing experience supporting pharmaceutical development
- Ability to analyze and interpret complex clinical data and scientific information
- Ensure accuracy and consistency when authoring documents
- Work collaboratively in a team-based environment
- Demonstrate expertise in medical writing best practices
- Experienced in leading the preparation of regulatory applications, including INDs and NDAs/BLAs
- Strong understanding of drug development process, including clinical research and regulatory requirements
- Understanding of the regulatory requirements of major agencies (e.g., FDA, EMA, MHRA, PMDA) and their differences
- Experienced in using industry standard technical tools (e.g., Microsoft Word macros) and electronic document management systems
- Committed to adhere to ethical principles and industry standards (GCP and GDP)
Benefits:
- Equity for full-time employees
- Comprehensive benefits including medical, dental, vision, and life/disability insurance
- Flexible paid time off
- 401(k) offerings (traditional, Roth, and employer match)
- Voluntary benefits like supplemental life insurance and legal services
- Mental health benefits through Employee Assistance Program for employees and their family
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