Verve Therapeutics, a Lilly Research Labs subsidiary, is a clinical-stage genetic medicines company on a mission to solve cardiovascular disease. Founded by leaders in cardiovascular medicine and gene editing, Verve is developing one-time gene editing treatments aimed at turning chronic management into a single-course cure.
Its lead programs target PCSK9 and ANGPTL3 to lower LDL-C, the root cause of cardiovascular disease.
The Associate Director-Medical Writer will be responsible for leading and driving the development of high-quality scientific and clinical documents for regulatory submissions and internal communications, ensuring accuracy, clarity, and adherence to company standards and regulatory guidelines.
- Lead the planning, authoring, and review of complex clinical and regulatory documents, including but not limited to Clinical Protocols, Investigator's Brochures (IBs), Clinical and Nonclinical Investigational Medicinal Product Dossiers (IMPDs), regulatory submission documents (e.g., IND/NDA/BLA modules), Clinical Study Reports (CSRs), and briefing documents.
- Manage multiple writing projects concurrently, ensuring prompt delivery and quality of all assigned documents.
- Collaborate effectively with cross-functional teams, including clinical development, regulatory affairs, biostatistics, medical affairs, nonclinical, and legal, to gather necessary information and ensure scientific accuracy and consistency across documents.
- Interpret and synthesize complex scientific and clinical data from various sources into clear, concise, and scientifically sound written communications.
- Provide strategic input on document content and messaging, ensuring alignment with project objectives and regulatory requirements.
- Mentor and provide guidance to junior medical writers, fostering their professional development.
- Develop and maintain a strong understanding of relevant therapeutic areas, drug development processes, and applicable regulatory guidelines (e.g., ICH, FDA, EMA).
- Engage in the development and implementation of medical writing standards, templates, and guidelines.
- Represent medical writing at internal and external meetings.
- Bachelor's degree in a relevant scientific field required; Master's or PhD preferred.
- Minimum of 8 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Demonstrated expertise in authoring a wide range of regulatory documents (CSRs, IBs, protocols, regulatory submissions).
- Strong understanding of drug development processes, clinical trial design, biostatistics, and regulatory requirements.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management systems.
- Experience in leading or mentoring junior writers is highly desirable.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $187,000