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 Now
Apply Now
• 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 Now
Apply Now