Director of Medical Writing

About Madrigal:Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.Role Overview:Director of Medical WritingMadrigal 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 non-alcoholic steatohepatitis (NASH).Position Responsibilities: 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 goalsSupport medical affairs to ensure alignment between publications and congress presentations and clinical documentsEnsure 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.Qualifications and Skills Required:10+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug developmentPhD or PharmD in Scientific Area preferredExperience in metabolic diseases, diabetes, cardiovascular diseases, or liver diseases preferredFamiliarity with designing and operationalizing clinical studies preferredExperienced in contributing to the preparation of regulatory applications, including INDs and NDAs/BLAs and other global submissionsStrong understanding of drug development process, including clinical research, regulatory requirements, and publication strategiesUnderstanding of the regulatory requirements of major agencies (e.g., FDA, EMA, MHRA, PMDA) and their differencesExperienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systemsAble to:Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiencesEnsure accuracy and consistency in the quality control of documents with precise attention to detailWork collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexityCommitted to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP)Compensation:Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.SummaryLocation: Conshohocken, PA, United StatesType: Full TimeExperience: Senior Manager/SupervisorDepartment: Medical Writing