Senior TMF Specialist

Job description

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook . Role Summary: The Sen i or TMF Specialist suppo rts th e ongoing mainte nance, qual it y, and inspect ion read iness of the Trial Master File (TMF) across assigned cl inical stud ies. This role is responsible for the integrity, completeness and compliance of our TMF including accurate filing, tracking, and quality control of TMF documents in accordance with ICH-GCP, the TMF Reference Model, and company procedures. This role requires a deep understanding of regulatory requirements and industry best practices...