Director, Medical Writing

Madrigal Pharmaceuticals • Washington, DC

1d

About The Position

Madrigal Pharmaceuticals is seeking a highly experienced Director of Medical Writing. The successful candidate will play a crucial role in ensuring the accuracy, consistency and quality of clinical and regulatory 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).

Requirements

• At least 12 years of clinical or regulatory medical writing experience supporting pharmaceutical 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 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 and other global submissions
• Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies
• 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., 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)

Nice To Haves

• Advanced degree in scientific area
• Experience in liver, cardiovascular or metabolic diseases

Responsibilities

• Provide strategic medical writing leadership for documents supporting Phase 1 though IV clinical trials (eg, clinical study protocols, clinical study reports) and regulatory filings and interactions (eg, summary documents, briefing books), ensuring that clinical and regulatory documents support program goals and timelines
• Collaborate closely with cross-functional teams to synthesize development strategies into study designs
• Author documents with a precise eye for detail and accuracy and for global regulatory requirements and industry best practices
• 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.

Benefits

• All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create.
• By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
• Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
• In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.
• The company also provides other benefits in accordance with applicable federal, state, and local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed