Senior Medical Writer, Nonclinical Development - Verve Therapeutics, Inc.

The Position

This position is responsible for independently managing the development and authoring of complex nonclinical documents. Nonclinical writing deliverables include nonclinical study reports and documents that support regulatory submissions across product development from discovery to Phase 1 and beyond. This role may also manage the development of components of complex integrated regulatory documents or scientific publications.

Job Responsibilities

• In coordination with cross-functional team members, drafts, edits, formats, and finalizes nonclinical study reports and regulatory documents to support regulatory submissions.
• Project manages medical writing deliverables, including development of timelines and communication with cross-functional team members and/or external CROs to maintain awareness of expectations, milestones, and deliverables.
• Coordinates with cross-functional teams and/or external CROs to produce clearly written, high-quality, and scientifically accurate documents and ensure consistency between related documents.
• Acts as a scientific contributor and subject matter expert who interprets data and applies knowledge to support high-quality and timely document preparation.
• Demonstrates competency in writing, editing, and reviewing nonclinical and regulatory documents per company standards and other guidelines.
• Seeks advice from management and others as needed to help identify and solve issues associated with documents.
• Act as a subject matter expert on various software tools used in authoring and review, including, but not limited to, Microsoft Word, Adobe Acrobat, Veeva Vault Submissions, Smartsheets, and PleaseReview.
• Performs primary literature searches related to documents.
• Performs and/or manages quality control reviews of nonclinical and regulatory documents
• Other responsibilities as assigned.

Qualifications

• Bachelor's degree is required in relevant field with at least 5 years of experience writing nonclinical/clinical/regulatory documents for a research organization, pharmaceutical company, 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 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.
• Self-motivated and independent work style with the ability to initiate and follow through on assignments in timely fashion.
• Experience with Graphpad Prism, PleaseReview, Veeva RIM, Benchling, and Smartsheet software programs is desirable.