Associate Director of CMC and Nonclinical Writing
Margaret has more than 15 years of experience in the biotech and pharmaceutical industry.
Margaret Studzinska leads global CMC and Nonclinical Writing at MMS. She and her team are responsible for developing efficient plans for CMC and nonclinical submission documents while maintaining quality and regulatory compliance. Margaret has more than 15 years of experience in the biotech and pharmaceutical industry.
Margaret manages a diverse team of CMC and nonclinical experts, providing services supporting submissions across all stages of drug development for small molecules and biotech drugs. She has built the CMC and nonclinical service line from the ground up by developing and executing a service level strategy, resourcing plans, and service expansion plans.
Prior to MMS, Margaret was a Project Manager in CMC at a biopharmaceutical company, responsible for overseeing CMC operations, manufacturing, and regulatory CMC submissions for IND, NDA, MAA, CTA, and ANDA dossiers. She also has experience in clinical operations and clinical research monitoring.
She holds a Master of Business Administration as well as a Certification in GCP for Clinical Research Professionals.
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