Associate Director, Medical Writing

8 Days Old

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and 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. The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position manages medical writing activities for one or more clinical programs and collaborates with functions such as clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs. The role operates with limited supervision to ensure deliverables are of high quality, completed on time, and compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The position may require authoring and reviewing clinical, nonclinical, and regulatory documents and may involve leading strategic discussions to ensure aligned messaging throughout regulatory documentation. Outstanding communication skills are essential. This role is based in Waltham, MA with hybrid work flexibility.
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Location:
Waltham, MA, United States
Salary:
$150,000 - $200,000
Category:
Management & Operations

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