Das ist der Job
At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
Darum lohnt es sich
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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
Role Summary The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents.
This position is responsible for the medical writing activities for one or more clinical programs and will interact with other functions (eg, clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs) as necessary.
This position will function with limited supervision as required and ensures deliverables are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. Previous experience in authoring and reviewing clinical, nonclinical, and regulatory documents is desired.
The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical.
