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Director of Medical Writing - Remote

Posted 12 weeks ago
Writing
Full Time
USA

Overview

Madrigal Pharmaceuticals is seeking a highly experienced Director of Medical Writing to ensure the accuracy, consistency, and quality of clinical and regulatory documents in support of transformative therapies for patients with metabolic diseases.

In Short

  • Provide strategic medical writing leadership for clinical trial documents.
  • Collaborate with cross-functional teams for alignment on program goals.
  • Ensure high-quality regulatory and clinical documents compliance.
  • Contribute to process development for document efficiency.
  • Stay updated with regulatory guidelines and industry trends.
  • Represent the company at industry conferences.

Requirements

  • 10+ years of medical writing experience in pharmaceutical development.
  • PhD or PharmD in a relevant scientific area preferred.
  • Experience in metabolic diseases preferred.
  • Familiarity with clinical study design.
  • Strong understanding of drug development processes.
  • Knowledge of regulatory requirements from major agencies.
  • Experience with technical tools and document management systems.
  • Able to analyze complex data and write clear documents.
  • Attention to detail and collaborative work ethic.
  • Commitment to ethical principles and industry standards.

Benefits

  • Flexible paid time off (PTO).
  • Medical, dental, and vision insurance.
  • Life and disability insurance.
  • Bonus and equity eligibility.
Madrigal Pharmaceuticals Corporation logo

Madrigal Pharmaceuticals Corporation

Madrigal Pharmaceuticals Corporation is a biopharmaceutical company focused on developing innovative therapies for non-alcoholic steatohepatitis (NASH), also referred to as metabolic dysfunction associated steatohepatitis (MASH). The company has achieved a significant milestone with the accelerated approval of its first therapy, Rezdiffra (resmetirom), by the U.S. Food and Drug Administration (FDA) for treating adults with NASH who have moderate to advanced liver fibrosis. Madrigal is currently conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis, demonstrating its commitment to addressing critical unmet medical needs in liver disease.

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