Director, Medical Writing

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February 22

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Madrigal Pharmaceuticals

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Pharmaceuticals • Biotechnology • Healthcare Insurance

Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.

51 - 200 employees

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $259M Post-IPO Equity on 2022-12

📋 Description

• Provide strategic medical writing leadership for documents supporting Phase 1 though IV clinical trials, which may include clinical study protocols, clinical study reports, investigators brochures, and regulatory documents (e.g., briefing books, summary documents) • Collaborate closely with cross-functional teams, including clinical operations, clinical development, biostatistics, pharmacovigilance, and regulatory affairs, to ensure alignment between medical writing activities and program goals • Support medical affairs to ensure alignment between publications and congress presentations and clinical documents • Ensure that regulatory and clinical 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 • Contributes 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 • Represent the company at industry conferences and meetings

🎯 Requirements

• 10+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development • PhD or PharmD in Scientific Area preferred • Experience in metabolic diseases, diabetes, cardiovascular diseases, or liver diseases preferred • Familiarity with designing and operationalizing clinical studies preferred • Experienced in contributing to 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 • 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 • Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP)

🏖️ Benefits

• Flexible paid time off (PTO) • Medical, dental, vision, and life and disability insurance