Director - Medical Writing

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 • 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 insurance • dental insurance • vision insurance • life insurance • disability insurance Apply tot his job Apply To this Job