Manager, Medical Writing Operations

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. 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).

Overview

Madrigal Pharmaceuticals is seeking a Medical Writing Operations. The successful candidate will play a crucial role in ensuring the accuracy, consistency, quality and archiving of R&D 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

• Provide technical editing and/or quality control checks on R&D documents, including
• Work with regulatory operations to ensure that documents are formatted correctly and are submission ready
• Work with clinical operations to prepare clinical study report appendices
• Create, update, and maintain document templates
• Compile relevant publications and references
• Archive documents appropriately in the electronic document management system (EDMS)
• Contribute 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

Qualifications

• Bachelor’s degree in a relevant field
• 3+ years of experience with document QC and publishing in a pharmaceutical or biotech company or CRO
• Knowledgeable about technical requirements for submissions
• Adept in MS Word and Adobe Acrobat and can teach others; willing to learn new software as needed
• Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems
• Committed 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.

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.

Please be aware that we are currently receiving numerous 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. Interviews with Madrigal are conducted via the Zoom platform.

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 Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.