Company Overview

Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA.  A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations.  

We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview:

The Director of Medical Writing organizes the development of major clinical and regulatory submissions, including, but not limited to, briefing books for regulatory agencies, clinical trial protocols and investigator brochures. This role oversees the authorship of key company documents, providing instruction and guidance to subject matter experts within non-clinical disciplines, as well as authoring or delegating authorship of clinical subject materials.  This role will have content matter expertise of requirements for key regulatory documents, and will need to acquire technical understanding of gene therapy and the therapeutic areas under investigation. This role will operate in a matrixed environment including extensive collaboration with non-clinical research, regulatory affairs and clinical development.  This role will require both the capacity to independently author documents, as well as to develop and manage internal reports as well as external medical writing vendors.  

Key Responsibilities:

  • Manages development of clinical and regulatory documents, including briefing books, clinical trial protocols, and investigator brochures, providing guidance to key stakeholders
  • Independently authors clinical sections of regulatory documents, under direction of clinical development
  • Helps recruit and build out team of medical writers
  • Identifies and supervises external medical writing contract support, as necessary
  • Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents
  • Provides strategic guidance to clinical regulatory team in matters pertaining to medical writing
  • Develop timelines and budget for medical writing support, as needed


  • Bachelor’s degree in relevant discipline required; PhD in biological sciences or related field preferred (BS 15+, MS 10+, PhD 8+ years ) years post-graduate experience in scientific or medical writing, in the biopharmaceutical industry
  • Demonstrated understanding and ability to gain knowledge of novel complex scientific concepts, and familiarity with medical terminology
  • Experience authoring and extensive understanding of requirements for regulatory submissions, including Investigational New Drug applications, Biologic Licensing Applications, clinical trial protocols and Investigator Brochures
  • Experience managing direct reports and/ or managing medical writing vendors
  • Working on cross-functional teams, providing subject matter guidance
  • Ability to clearly communicate timelines, deliverables and budget

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

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