Backed by Atlas Venture.
About the role
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), Pompe disease and multiple DMD mutations.
What they're looking for
- Doctorate degree in a scientific or healthcare discipline required, PharmD, PhD, MD, or equivalent preferred
- 8+ years of relevant experience including 5+ in Medical Information, medical review, medical communications, Medical Affairs, or a related function within the pharmaceutical, biotechnology, or healthcare industry
- Experience serving as a medical reviewer for promotional and non-promotional materials through Medical, Legal, Regulatory, and/or Promotional Review Committee processes
- Strong understanding of FDA regulations, industry guidance, and compliance expectations governing Medical Information, scientific exchange, promotional review, and non-promotional communications
- Experience developing, reviewing, and maintaining Medical Information response documents, FAQs, scientific summaries, or related medical/scientific content
- Ability to interpret and communicate complex scientific and clinical data clearly, accurately, and appropriately for internal and external audiences
More about this role
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), Pompe disease and multiple DMD mutations. 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 .
The Associate Director, Medical Information and Review plays a critical role in building and executing Dyne’s Medical Information and medical review capabilities as the organization advances toward commercialization and launch readiness. This role serves as a key Medical Affairs partner in the review of promotional and non-promotional materials, ensuring scientific accuracy, medical integrity, fair balance, and alignment with applicable regulatory, legal, compliance, and company standards. The Associate...
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