Nonclinical Medical Writer

The Company

Verve Therapeutics is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics, and gene-editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve’s gene-editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. The company is advancing a pipeline of precision genetic medicines, led by VERVE-101, which is being developed initially for heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease. In 2020 and 2021, Verve was selected as a Best Places to Work by the Boston Business Journal and one of the Endpoints 11, which recognizes the most promising startups in biotech. Verve is headquartered in Cambridge, Massachusetts.

The Position

The Nonclinical Medical Writer is responsible for the development of nonclinical documents that support regulatory submissions as well as publications and presentations.  This position will report to the Senior Director, Preclinical Pharmacology and Translational Medicine.

Responsibilities:

• Independently prepares complex nonclinical and regulatory documents to support IND submissions and clinical trial applications including, but not limited to, protocols, study reports, investigator brochures, and IND/IMPD sections.
• Efficiently manages nonclinical medical writing projects including timelines, content development, review cycles, and communication with cross-functional team members to maintain awareness of expectations, milestones, and deliverables
• Acts as a scientific contributor and subject matter expert who interprets data and applies knowledge of regulatory and scientific requirements to support document preparation
• Effectively coordinates with cross-functional teams to produce clearly written, high-quality, and scientifically accurate documents and ensure consistency between related documents
• Demonstrates high competency in writing, editing, and reviewing nonclinical, clinical, and regulatory documents per company and other guidelines
• Able to identify and solve issues associated with nonclinical medical writing, seeks advice from management and others as needed, and exercises negotiation and communication skills with cross-functional team members
• Performs and/or manages quality control reviews of nonclinical and regulatory documents

Education/Experience:

• Bachelor's degree is required. Master's degree or Ph.D. in a scientific discipline preferred
• At least 5 years of experience writing nonclinical/clinical/regulatory documents for a pharmaceutical or biotechnology company. Strong background in writing nonclinical documents preferred.
• Understanding of FDA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production, including a solid understanding of CTD structure and content
• Strong attention to detail and ability to comply with company style guides and templates
• Excellent writing, presentation, and project management skills
• Ability to create strong, collaborative working relationships

EEO Statement

Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & Staffing Agencies

Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.