This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences, and includes aligning DSS study teams with program- and study-level strategies. For assigned programs and studies, the role leads the DSS Study Team and represents DS as a member of the cross-functional study team. The role also utilizes operational analytics and project management tools to optimize execution of programs and studies.
The Specialist, Regulatory and PV Network provides the strategy based on regulatory requirements and completes regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. The Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.
Seeking an Associate Director in Regulatory, CMC to independently lead, contribute and execute on CMC regulatory activities in support of Deciphera’s studies across all stages of clinical drug development. The primary responsibility will be to generate high quality and compliant CMC regulatory submissions for global investigational applications, initially focusing on oligonucleotide products. This is a hybrid role based out of our Waltham, MA office.
As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects, drive strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies, and ensure compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.