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.OverviewMadrigal 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 liver disease, primarily metabolic dysfunction-associated steatohepatitis (MASH).Responsibilities<ul><li>Provide strategic medical writing leadership for documents supporting Phase 1 though IV clinical trials (eg, clinical study protocols, clinical study reports) and regulatory filings and interactions (eg, summary documents, briefing books), ensuring that clinical and regulatory documents support program goals and timelines</li><li>Collaborate closely with cross-functional teams to synthesize development strategies into study designs</li><li>Author documents with a precise eye for detail and accuracy and for global regulatory requirements and industry best practices</li><li>Contribute to the development and implementation of processes and systems to optimize Madrigal’s efficiency and productivity in document development</li><li>Stay current with regulatory guidelines, industry trends, and best practices in medical writing.</li></ul>Qualifications<ul><li>At least 12 years of clinical or regulatory medical writing experience supporting pharmaceutical development</li><li>Able to:<ul><li>Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences</li><li>Ensure accuracy and consistency when authoring documents</li><li>Work collaboratively in a team-based environment</li><li>Demonstrate expertise in medical writing best practices</li></ul></li><li>Experienced in leading the preparation of regulatory applications, including INDs and NDAs/BLAs and other global submissions </li><li>Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies</li><li>Understanding of the regulatory requirements of major agencies (e.g., FDA, EMA, MHRA, PMDA) and their differences</li><li>Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems</li><li>Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP)</li><li>Preferred:<ul><li>Advanced degree in scientific area</li><li>Experience in liver, cardiovascular or metabolic diseases</li></ul></li></ul>All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for 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. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our <a target="_blank" href="https://madrigalpharma.wd501.myworkdayjobs.com/Madrigal">Madrigal Careers</a> site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to <a target="_blank" href="mailto:HR@madrigalpharma.com">HR@madrigalpharma.com</a>.

Director, Medical Writing

Description

Madrigal Pharmaceuticals

Pipeline