Executive Director, Global Operations
Ms. Gayari has over 20 years experience in clinical research including career highlights at Pfizer where she led all programming efforts across Phases I-III studies for all indications of Lyrica® and several other CNS compounds. Her areas of expertise include rapid response to submissions and developing requirements and displays for special safety topics and integrated summary documents. Her broad experience includes several successful submissions in both the US and EU, for NDAs/ MAAs and for supplements.
As Executive Director, Global Operations at MMS Holdings, Inc., Ms. Gayari leads the technical functions globally for all MMS offerings including medical writing, biostatistics, safety and regulatory affairs. Her teams are experienced in supporting a variety of submissions for both small and large pharma including all aspects of clinical development, from developing EDC systems, SAPs and protocols to creating CDISC and integrated datasets and creating eCTDs for both US and EU submissions. MMS teams have supported submissions that involve large amount of legacy data through acquisitions / merger submissions with varied datasets and other scenarios. The teams also have experience in supporting a variety of other documents such as drug development plans, safety updates, product defense, IBs, CSRs, protocols, narratives, REMS, RMPs and disclosures for pipelines in a timely manner.
Michelle completed her BS in Statistics, Mathematics, and Psychology from Central Michigan University. Michelle is a CDISC associate member and invited speaker at many forums including RAPS and DIA.