Madrigal Pharmaceuticals Corporation is hiring: Director, Medical Writing in Con

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 Writing

Madrigal 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:

1. Provide strategic medical writing leadership for documents supporting Phase 1 through IV clinical trials, which may include clinical study protocols, clinical study reports, investigators brochures, and regulatory documents (e.g., briefing books, summary documents).
2. 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.
3. Support medical affairs to ensure alignment between publications and congress presentations and clinical documents.
4. Ensure 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.
5. Contribute to the development and implementation of processes and systems to optimize Madrigal’s efficiency and productivity in document development.
6. Stay current with regulatory guidelines, industry trends, and best practices in medical writing.
7. Represent the company at industry conferences and meetings.

Qualifications and Skills Required:

1. 10+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development.
2. PhD or PharmD in Scientific Area preferred.
3. Experience in metabolic diseases, diabetes, cardiovascular diseases, or liver diseases preferred.
4. Familiarity with designing and operationalizing clinical studies preferred.
5. Experience in contributing to the preparation of regulatory applications, including INDs and NDAs/BLAs and other global submissions.
6. Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies.
7. Understanding of the regulatory requirements of major agencies (e.g., FDA, EMA, MHRA, PMDA) and their differences.
8. Experience in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems.
9. 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.
10. 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.