3 jobs found in Waltham

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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 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. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 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...

Responsibilities: Primary coding resource for assigned products and studies. ccurately codes assigned data fields including, but not limit ed to, adverse events using MedDRA and concomitant medications using WHO Drug in accordance with company coding conventions and ATC. Effectively performs coding related functions for assigned studies. Prepare and manage coding assignments for new studies and collaborate with clinical team representatives on approach to coding strategy for assigned products and oversight of assigned studies including sign off document as it impacts medical coding review, product approval, analysis of coded data for safety review and signal detection and patient safety. Identifies when terms or drug names are inadequate, ambiguous or unclear for coding purposes and direct query generation in such aspects. lso, identify and resolve coding discrepancies, and review coding listings for accuracy and consistency. Participate in...