Associate Director, Medical Writing

Role Summary

Associate Director, Medical Writing at Madrigal Pharmaceuticals. The successful candidate will play a crucial role in ensuring the accuracy, consistency and quality of clinical documents. This role is critical in supporting the company’s mission to develop transformative therapies for patients with liver disease, primarily metabolic dysfunction-associated steatohepatitis (MASH).

Responsibilities

• Write documents supporting Phase 1 through IV clinical trials (primarily clinical study protocols, clinical study reports and investigators brochures)
• Collaborate closely with cross-functional teams to create documents that support program goals and timelines
• Ensure that documents are of the highest quality and compliant with global regulatory requirements and industry best practices. This role may also include contributing to updates to standard operating procedures to reflect evolving requirements.
• Contribute to the development and implementation of processes and systems to optimize Madrigal’s efficiency and productivity in document development
• Stay current with regulatory guidelines, industry trends, and best practices in medical writing

Qualifications

• 6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development
• Able to:
  • Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences
  • Ensure accuracy and consistency in the quality control of documents with precise attention to detail
  • Work collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexity
• Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies
• Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems
• Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP)
• Preferred :
  • Familiarity with designing and operationalizing clinical studies
  • Advanced degree in scientific area
  • Experience in liver, cardiovascular or metabolic diseases