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Date Posted
Today
New!Remote Work Level
100% Remote
Location
Remote in Boston, MA
Job Schedule
Full-Time
Salary
$155,000 - $189,000 Annually
Benefits
Unlimited or Flexible PTO Health Insurance Dental Insurance Vision Insurance Life Insurance Retirement Savings Disability Paid Time Off
Categories
Editing, Healthcare, Pharmaceutical, Product Manager, Project Manager, Research, Writing
About the Role
Title: Senior Manager, Medical Writing
Location: Boston, MA - Remote
Job Description:
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.
Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).
Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.
Overview
Madrigal Pharmaceuticals is seeking an Senior Manager of Medical Writing. The successful candidate will play a crucial role in ensuring the accuracy, consistency and quality of clinical documents. This role is critical in supporting the company’s mission to develop transformative therapies for patients with liver disease, primarily metabolic dysfunction-associated steatohepatitis (MASH).
Responsibilities
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Write documents supporting Phase 1 though IV clinical trials (primarily clinical study protocols, clinical study reports and investigators brochures)
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Collaborate closely with cross-functional teams to create documents that support program goals and timelines
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Ensure that 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.
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Contribute to the development and implementation of processes and systems to optimize Madrigal’s efficiency and productivity in document development
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Stay current with regulatory guidelines, industry trends, and best practices in medical writing
Qualifications
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6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development
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Able to:
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Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences
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Ensure accuracy and consistency in the quality control of documents with precise attention to detail
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Work collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexity
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Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies
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Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems
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Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP)
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Preferred :
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Familiarity with designing and operationalizing clinical studies
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Advanced degree in scientific area
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Experience in liver, cardiovascular or metabolic diseases
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Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $155,000 to $189,000 per year.